Title Page
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Conducted on
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Prepared by
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Location
General Information
General Information
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Distributor Name:
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Distributor Full Address:
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City, State/Province, Zip/Postal Code, Country
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Total Employees
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No. of Warehouse Employees
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No. of Office Employees
Facility Information
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Facility Built in Year (YYYY):
Building Construction Material:
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Is there a Quarantine area?
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Total Facility Area (Sq. Ft.):
Warehouse
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(Sq. Ft.):
Office
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(Sq. Ft.):
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Are there security controls?
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CCTV Camera
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Badge Access Key Access
Burglar Alarm Fire Detection/Suppression
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Pest Control Provider
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Pest Control Frequency
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Calibration Provider
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Calibration Frequency
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Housekeeping Provider
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Housekeeping Frequency
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Are you also and importer for Asset?
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Is there an ERP System?
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Yes, Specify Name: No, Describe how resource planning is managed:
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Is there a temperature monitoring/control system?
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Yes, Specify Name:
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Do you use a 3PL?
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Yes, Specify your 3PL:
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Do you distribute products that require special storage requirement?
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Do you perform any relabeling activities including instructions for use per country specific languages or market requirement?
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Yes, Specify your relabeling activities:
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Do you have a Distribution Agreement with Asset?
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Does it comply with MDR?
Quality Management System (QMS) Requirements
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Is there a documented QMS?
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Is there a change control process to identify, document and assess changes introduced and how changes may affect compliance and performance of medical devices? (Such changes may have a significant impact and may have the potential to affect the performance of medical device distributed, i.e. setting of a heating/cooling system, relocating storage area, etc.)
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Is there a document control and record control procedure? (This shall include complaint, adverse events, recalls/field safety notices, distribution records management and demonstration of traceability)
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Is there a training procedure that describes a documented training program to ensure personnel are competent in performing their respective duties?
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Is there a purchasing control procedure to qualify suppliers including your transportation partners?
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Is there a complaint handling procedure to ensure appropriate economic operators such as Competent Authorities, Authorized Representatives and Importers are notified promptly?
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Is there an investigation procedure to log complaints and investigate complaints related to distribution?
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Is there an adverse event reporting procedure to ensure appropriate supply chain partners such as Competent Authorities, Authorized Representatives and Importers are notified promptly?
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Is there a recall and/or field safety corrective action procedure to ensure recall/field safety corrective actions are conducted in a timely manner AND prevent recalled products re-entering supply chain?
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Is there a control of non-conforming product procedure to log such incidents and prevent defective product entering market? (This shall include non-salable products such as damaged, expired, recalled or falsified products)
Distribution Requirements
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Is there a receiving procedure that describe methods of verification and inspection activities to confirm: a). presence of CE mark; b). a declaration of conformity of the device has been drawn up; c). an UDI has been assigned by the manufacturer where applicable; d). the importer is identified?
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Is there an inventory control procedure that ensures stock rotations are conducted AND First In First Out (FIFO)?
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Is there a storage procedure to ensure products storage conditions comply with conditions set by the manufacturer? (This shall include product that requires controlled temperature storage if applicable and temperature excursion action levels)
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Is there a procedure that describes returned product handling to prevent non-salable product re-entering supply chain (This shall include customer returns of recalled products)?
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Is there a medical device disposal procedure that prevents non-salable products such as expired product, damaged product, recalled product, falsified products from re-entering supply chain and the disposal of such products are conducted according to local environmental regulations?
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Is there a procedure that describes handling of customer orders including pick, pack and ship?
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Are there distribution records that maintain traceability of medical devices sold to customer?
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Is there a process control to ensure the product transportation conditions comply with conditions set by the manufacturer?
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Is there a Disaster Recovery Plan and/or Business Contingency Plan in place?