Regulatory Open Forum

I am looking for some insight on how to address Suppliers and supplier requirements. We are a samll company (30 people), we received FDA clearance in 2013. Right now our supplier process is very basic. I don't believe that it would stand up to an FDA audit. From experience what do we need to have in place. We don't do supplier audits, we don't have a SCAR process, we don't have defined documentation for the suppliers that we have. We have said that we 'grandfathered' them all in once we created the QMS. I don't believe that this is acceptable but would like to understand at minimum what do I need. Once I have that stuff in place then I can start to implement the other items.

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

As for "Suppliers and Supplier Requirements," it falls under Purchasing Control.

Good practices include, but not limited to, understanding what FDA usually examines during inspection.  

FDA verifies:

1. SOPs (requirements for suppliers, consultants,and contractors).
2. Qualification process - how you evaluate and select them.
3. Your type and extent of control defined - evaluation criteria.
4. Your records of acceptable suppliers, consultants, contractors, etc.
5. Your written, approved and specified reqs for your products/services received.

You can also refer to auditing guidelines to check your existing SOPs (if it is to be implemented) cover the necessary requirements.   

As a side note, although it is not required, it is highly recommended you please audit the suppliers onsite for some justifiable reasons. 
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President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
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Original Message:
Sent: 01-28-2014 14:35
From: Keri Froese
Subject: Supplier Expectations

I am looking for some insight on how to address Suppliers and supplier requirements. We are a samll company (30 people), we received FDA clearance in 2013. Right now our supplier process is very basic. I don't believe that it would stand up to an FDA audit. From experience what do we need to have in place. We don't do supplier audits, we don't have a SCAR process, we don't have defined documentation for the suppliers that we have. We have said that we 'grandfathered' them all in once we created the QMS. I don't believe that this is acceptable but would like to understand at minimum what do I need. Once I have that stuff in place then I can start to implement the other items.

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

You might refer to the GHTF guidance on control of products and services from suppliers, SG3/N17.  It contains all of the information that FDA uses in its application of 21 CFR 820.50 Purchasing Controls.  The guidance can be found at www.imdrf.org under GHTF documents.

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Edwin Bills RAC
Principal Consultant
ELB Consulting
Butler KY
United States
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Original Message:
Sent: 01-29-2014 08:54
From: Chang Lim
Subject: Supplier Expectations

As for "Suppliers and Supplier Requirements," it falls under Purchasing Control.

Good practices include, but not limited to, understanding what FDA usually examines during inspection.  

FDA verifies:

1. SOPs (requirements for suppliers, consultants,and contractors).
2. Qualification process - how you evaluate and select them.
3. Your type and extent of control defined - evaluation criteria.
4. Your records of acceptable suppliers, consultants, contractors, etc.
5. Your written, approved and specified reqs for your products/services received.

You can also refer to auditing guidelines to check your existing SOPs (if it is to be implemented) cover the necessary requirements.   

As a side note, although it is not required, it is highly recommended you please audit the suppliers onsite for some justifiable reasons. 
-------------------------------------------
President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 01-28-2014 14:35
From: Keri Froese
Subject: Supplier Expectations

I am looking for some insight on how to address Suppliers and supplier requirements. We are a samll company (30 people), we received FDA clearance in 2013. Right now our supplier process is very basic. I don't believe that it would stand up to an FDA audit. From experience what do we need to have in place. We don't do supplier audits, we don't have a SCAR process, we don't have defined documentation for the suppliers that we have. We have said that we 'grandfathered' them all in once we created the QMS. I don't believe that this is acceptable but would like to understand at minimum what do I need. Once I have that stuff in place then I can start to implement the other items.

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

While I posted the information on the GHTF document which clearly is a devices document, the principles in that document apply to any product, drug, device, or other non-medical product.  It is a valuable reference for those who have responsibilities in the area of purchased product or service.  The information is similar to the training that all FDA investigators have received and therefor would be helpful during an inspection.

-------------------------------------------
Edwin Bills RAC
Principal Consultant
ELB Consulting
Butler KY
United States
-------------------------------------------






Original Message:
Sent: 01-29-2014 13:56
From: Chang Lim
Subject: Supplier Expectations

As for "Suppliers and Supplier Requirements," it falls under Purchasing Control.

Good practices include, but not limited to, understanding what FDA usually examines during inspection.  

FDA verifies:

1. SOPs (requirements for suppliers, consultants,and contractors).
2. Qualification process - how you evaluate and select them.
3. Your type and extent of control defined - evaluation criteria.
4. Your records of acceptable suppliers, consultants, contractors, etc.
5. Your written, approved and specified reqs for your products/services received.

You can also refer to auditing guidelines to check your existing SOPs (if it is to be implemented) cover the necessary requirements.   

As a side note, although it is not required, it is highly recommended you please audit the suppliers onsite for some justifiable reasons. 
-------------------------------------------
President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 01-28-2014 14:35
From: Keri Froese
Subject: Supplier Expectations

I am looking for some insight on how to address Suppliers and supplier requirements. We are a samll company (30 people), we received FDA clearance in 2013. Right now our supplier process is very basic. I don't believe that it would stand up to an FDA audit. From experience what do we need to have in place. We don't do supplier audits, we don't have a SCAR process, we don't have defined documentation for the suppliers that we have. We have said that we 'grandfathered' them all in once we created the QMS. I don't believe that this is acceptable but would like to understand at minimum what do I need. Once I have that stuff in place then I can start to implement the other items.

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

Drugs or devices?

-------------------------------------------
Julie Omohundro RAC
Durham NC
United States

Original Message:
Sent: 01-29-2014 08:20
From: Keri Froese
Subject: Supplier Expectations

I am looking for some insight on how to address Suppliers and supplier requirements. We are a samll company (30 people), we received FDA clearance in 2013. Right now our supplier process is very basic. I don't believe that it would stand up to an FDA audit. From experience what do we need to have in place. We don't do supplier audits, we don't have a SCAR process, we don't have defined documentation for the suppliers that we have. We have said that we 'grandfathered' them all in once we created the QMS. I don't believe that this is acceptable but would like to understand at minimum what do I need. Once I have that stuff in place then I can start to implement the other items.

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

Devices.

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






Original Message:
Sent: 01-30-2014 13:06
From: Julie Omohundro
Subject: Supplier Expectations

Drugs or devices?

-------------------------------------------
Julie Omohundro RAC
Durham NC
United States

Original Message:
Sent: 01-29-2014 08:20
From: Keri Froese
Subject: Supplier Expectations

I am looking for some insight on how to address Suppliers and supplier requirements. We are a samll company (30 people), we received FDA clearance in 2013. Right now our supplier process is very basic. I don't believe that it would stand up to an FDA audit. From experience what do we need to have in place. We don't do supplier audits, we don't have a SCAR process, we don't have defined documentation for the suppliers that we have. We have said that we 'grandfathered' them all in once we created the QMS. I don't believe that this is acceptable but would like to understand at minimum what do I need. Once I have that stuff in place then I can start to implement the other items.

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