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This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this. 

Thanks.

I also work for a start-up company in the cardiovascular field and we use the following definition:

"A Crucial Supplier is a supplier delivering materials or components, the failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician or others, or could cause significant degradation in performance."

Unfortunately, this definition doesn't help on its own to limit the selection of crucial suppliers. I would caution against choosing too many as these would be subject to scrutiny by your NB. So, what we also do is consider the residual risks that "could cause unreasonable risk to the patient" and determine which raw materials or components would lead to the unreasonable risks. Without using the product residual risk rationale we were also ready to consider all our suppliers as crucial. Not a good idea!

I trust this helps and if I can clarify anything please let me know.
Best

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Malcolm Applewhite
QA/RA Manager
Cape Town
South Africa
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Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

I have worked with many start up and agree that the potential for patient harm is one component when assessing critical suppliers. Equally as important are other factors such their quality systems and processes and whether they are the only supplier of a particular item and so on. Ultimately you will end up with some sort of matrix and which will scale/group your suppliers in certain risk groups and you will take appropriate actions to mitigate/manage these risks.

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Jacques du Preez 
Psephos Biomedica
Brighton
United Kingdom
------------------------------

Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

One of the ways we look at suppliers to help define criticality is to look at whether the part goes through incoming inspection, can we catch the failure before it becomes part of the product. If that answer is no can we catch during in process checks. Will we catch it all the time or only a percentage of the time.

We also look at whether the failure of the part will cause patient harm. 

This is by no means the only way or the right way but it has worked for us.

------------------------------
Keri Froese RAC
Quality Assurance Manager
Dunrobin ON
Canada
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Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

See my blog on this topic, here excerpted: 
"subcontractors in charge of processes which are essential for ensuring compliance with legal requirements ('critical subcontractor') or a supplier of crucial components or of the entire devices (both: 'crucial supplier')".

If we think of subcontractors as responsible for processes and suppliers as responsible for components, the GHTF document is then useful in this regard (see page 11 of 21, GHTF/SG3/N17R9:2008). Manufacturers should consider identifying suppliers according to these terms for managing not only its supplier quality program, but also to provide meaningful direction to its registrar when the unannounced auditor knocks at the door. Suppliers that provide parts and components made to your specifications (e.g., mechanical, electrical, software) belong on your list of "crucial suppliers". Suppliers that provide services related to processes (e.g., sterilization, design, environmental monitoring, manufacturing) belong on your list of "critical subcontractors".

------------------------------
Michael Wienholt
Owner & Principal Consultant
Raleigh NC
United States
------------------------------

Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

I used to work at a small company as well and we had issues with supplier classification/ qualification as well. I conducted an FMEA for all the parts provided by all suppliers. Then, I had categorized the ranges of RPN into Class I suppliers, Class II suppliers and Class III/ critical suppliers. 
E.g. RPN 1-4 : Class I; RPN 4-8: Class II; RPN 8 and above :Class III and above. 
Hope this helps.
Good Luck!

------------------------------
Anjali Nair
Los Angeles, CA
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Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

This message was posted by a user wishing to remain anonymous

Our QMS, rather confusingly, use the term 'critical supplier' as part of covering 13485:2016 [7.4.1]; roughly summarised as ensuring suppliers are selected based on their ability, past performance, and the effect of the component on the device / risk associated with it failing in the device.

Your engineers may be thinking more along the lines of 'critical components', of which I have yet to find a solid definition. These are usually agreed with a 60601-1 test house; from experience, they have focused on flammability of components (most readily addressed by using UL-rated components). However, we have not produced life-supporting devices or anything where failure of which presents an unacceptable risk.

Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

In regard to critical components per IEC 60601-1 and Particular Standards (IEC 60601-2-XX or IEC/ISO 80601-2-XX) there is no specific term called critical components.  Critical components of the 60601 series of standards has nothing to do with Critical or Crucial Suppliers or Subcontractors.  A critical component is one that is relied on safety to meet the requirements of the 60601 standards.  There is a lot more to critical components than flammability of plastics.  Power supplies, fuses, power cords, relays (sometimes), transformers, opto-isolators, and many other components can be Critical Components.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 19-Jun-2019 12:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

Our QMS, rather confusingly, use the term 'critical supplier' as part of covering 13485:2016 [7.4.1]; roughly summarised as ensuring suppliers are selected based on their ability, past performance, and the effect of the component on the device / risk associated with it failing in the device.

Your engineers may be thinking more along the lines of 'critical components', of which I have yet to find a solid definition. These are usually agreed with a 60601-1 test house; from experience, they have focused on flammability of components (most readily addressed by using UL-rated components). However, we have not produced life-supporting devices or anything where failure of which presents an unacceptable risk.

Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

​Keep in mind the components called out in the CSA descriptive report are considered Critical Components.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 20-Jun-2019 01:17
From: Leonard Eisner
Subject: Critical suppliers

In regard to critical components per IEC 60601-1 and Particular Standards (IEC 60601-2-XX or IEC/ISO 80601-2-XX) there is no specific term called critical components.  Critical components of the 60601 series of standards has nothing to do with Critical or Crucial Suppliers or Subcontractors.  A critical component is one that is relied on safety to meet the requirements of the 60601 standards.  There is a lot more to critical components than flammability of plastics.  Power supplies, fuses, power cords, relays (sometimes), transformers, opto-isolators, and many other components can be Critical Components.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 19-Jun-2019 12:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

Our QMS, rather confusingly, use the term 'critical supplier' as part of covering 13485:2016 [7.4.1]; roughly summarised as ensuring suppliers are selected based on their ability, past performance, and the effect of the component on the device / risk associated with it failing in the device.

Your engineers may be thinking more along the lines of 'critical components', of which I have yet to find a solid definition. These are usually agreed with a 60601-1 test house; from experience, they have focused on flammability of components (most readily addressed by using UL-rated components). However, we have not produced life-supporting devices or anything where failure of which presents an unacceptable risk.

Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.

Why do you want to identify critical suppliers?

In my experience it is often part of a system to classify suppliers and create supplier controls. Such systems can easily grow complicated, commit device manufacturers to complex systems, and result in audit nonconformances because the company cannot sustain the system.

A common example is a requirement to conduct an annual QMS audit on such suppliers even though they have a QMS certificate from a trusted organization.

If you must define a critical supplier then use the definition from GHTF sg4-n84-2010 Auditing Device Manufacturers - Part 5 Control of Suppliers, section 5.3. A critical supplier is a supplier delivering materials, components, or services, that may influence the safety and performance of the product.

This means you need to identify the critical components. Any supplier that provides one or more critical components is a critical supplier.

The best method is look at the list of essential design outputs you created as part of 820.30(d). Identify the purchased components that support each essential design output. Follow the QSIT model that traces the essential design outputs through the production process to purchasing and incoming inspection.

These are the critical components and the supplier that provides them is a critical supplier.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 18-Jun-2019 14:59
From: Anonymous Member
Subject: Critical suppliers

This message was posted by a user wishing to remain anonymous

As a member of a small startup, we would like to know how the device industry defines critical suppliers.  I work with many engineers and we do not seem to have to good definition of critical suppliers. To them, everything is critical because the supplied parts all seem to affect patient safety.  I would like some opinion on this.

Thanks.