Regulatory Open Forum

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

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Kathy Mills
Global Representation Manager
United States
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In the US medical device kingdom, 

The term "critical" supplier generally refers to those providing device components essential to the performance of the device.  But it is up to the manufacturer to define what is essential or critical or not.  

When we say "critical" devices, we generally refer to those devices (e.g., surgical instruments including endoscopes).

Please note: a endoscope manufacturer has been sued by a high school student after a fatal "superbug" at 

http://wp.me/p5vHi0-NR

Those supplying device components to the surgical instruments or endoscopes can be called "critical supplier."  

Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------

I would add to David's definition, a critical supplier also refers to a supplier that provides a components or service that keeps an approved product on the market or investigational agent in a clinical trial.  These could be active ingredients, components, packaging materials, labels and labeling, etc.  If you depend on a supplier to do business, then they are critical.

All the best,

Dar

-------------------------------------------
Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
-------------------------------------------


Original Message:
Sent: 03-02-2015 16:57
From: David Lim
Subject: "critical supplier"

In the US medical device kingdom, 

The term "critical" supplier generally refers to those providing device components essential to the performance of the device.  But it is up to the manufacturer to define what is essential or critical or not.  

When we say "critical" devices, we generally refer to those devices (e.g., surgical instruments including endoscopes).

Please note: a endoscope manufacturer has been sued by a high school student after a fatal "superbug" at 

http://wp.me/p5vHi0-NR

Those supplying device components to the surgical instruments or endoscopes can be called "critical supplier."  

Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------

Dear Kathy,

There is a definition of "critical supplier" at GHTF document: GHTF/SG4/N84:2010.
See below and also link for full document:

"5.3 Critical supplier

A supplier delivering materials, components, or services, that may influence the safety and

performance of the product. (GHTF/SG4/N33)

Note:

 

In the context of audit of medical device manufacturers, a critical supplier is a

supplier of a product or service, the failure of which to meet specified requirements could

cause unreasonable risk to the patient, clinician or others, or could cause a significant

degradation in performance. This can include suppliers of services which are needed for

compliance with QMS or regulatory requirements, e.g. internal audit contractors or EU

Authorized Representatives."

http://www.imdrf.org/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-n84-2010-guidelines-for-auditing-qms-part-5-control-of-suppliers-100827.pdf

Kind Regards,
Claudia

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Claudia Meneghisse PHD, RAC
Tecan Schweiz AG
Meilen
Switzerland
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Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------

I had the exact same question previously and someone told me to think about it in the following way:

If the part fails what is the impact?
Is the part a custom part?
Is it a single source supplier?
Does the part require traceability?

As well some times it makes more sense to define part criticality rather  than supplier criticality.

Hope this helps.

-------------------------------------------
Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
-------------------------------------------


Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------

Keri,

Your points are very valid.

I would add the following:

When a firm develops a list of criteria determining "products or services" as "critical," it should be risk-based including various factors in addition to those that you have shared below.  


Original Message:
Sent: 03-03-2015 10:27
From: Keri Froese
Subject: "critical supplier"

I had the exact same question previously and someone told me to think about it in the following way:

If the part fails what is the impact?
Is the part a custom part?
Is it a single source supplier?
Does the part require traceability?

As well some times it makes more sense to define part criticality rather  than supplier criticality.

Hope this helps.

-------------------------------------------
Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
-------------------------------------------


Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------

Critical suppliers are designated by the legal manufacturer. I would choose suppliers providing critical processes, e.g. sterilization, critical components e.g. translation services for labelling or a contract manufacturer providing a finished device. The risk analysis will help to identify the critical suppliers for your device.

-------------------------------------------
Frederica Rancitelli-Mcmillan

Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------

Thank you, everyone, for your input. It is much appreciated.

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------


Original Message:
Sent: 03-03-2015 14:14
From: Frederica Rancitelli-Mcmillan
Subject: "critical supplier"

Critical suppliers are designated by the legal manufacturer. I would choose suppliers providing critical processes, e.g. sterilization, critical components e.g. translation services for labelling or a contract manufacturer providing a finished device. The risk analysis will help to identify the critical suppliers for your device.

-------------------------------------------
Frederica Rancitelli-Mcmillan

Original Message:
Sent: 03-02-2015 16:11
From: Kathy Mills
Subject: "critical supplier"

Good afternoon.
Being a global medical device manufacturer, I am having some difficulty advising on the identification of our critical suppliers. I see that both Canada and the EU (just for example) use the GHTF definition. Even so, the interpretation of this definition can be extremely broad. The FDA talks about "supplier" requirements in the QSR, but I cannot find a definition of "critical supplier." ISO 13485 7.4 outlines purchasing procedures, but again, doesn't specify "critical suppliers."

Would any of you be able to assist by replying with your manufacturer's definition of "critical supplier," along with some good examples of what is and is not deemed "critical?" 

Thank you!

-------------------------------------------
Kathy Mills
Global Representation Manager
United States
-------------------------------------------