Title Page

  • Conducted on

  • Prepared by

  • Location

General Information

General Information

  • Distributor Name:

  • Distributor Full Address:

  • City, State/Province, Zip/Postal Code, Country

  • Total Employees

  • No. of Warehouse Employees

  • No. of Office Employees

Facility Information

  • Facility Built in Year (YYYY):

Building Construction Material:

  • Is there a Quarantine area?

  • Total Facility Area (Sq. Ft.):

Warehouse

  • (Sq. Ft.):

Office

  • (Sq. Ft.):

  • Are there security controls?

  • CCTV Camera

  • Badge Access Key Access

Burglar Alarm Fire Detection/Suppression

  • Pest Control Provider

  • Pest Control Frequency

  • Calibration Provider

  • Calibration Frequency

  • Housekeeping Provider

  • Housekeeping Frequency

  • Are you also and importer for Asset?

  • Is there an ERP System?

  • Yes, Specify Name: No, Describe how resource planning is managed:

  • Is there a temperature monitoring/control system?

  • Yes, Specify Name:

  • Do you use a 3PL?

  • Yes, Specify your 3PL:

  • Do you distribute products that require special storage requirement?

  • Do you perform any relabeling activities including instructions for use per country specific languages or market requirement?

  • Yes, Specify your relabeling activities:

  • Do you have a Distribution Agreement with Asset?

  • Does it comply with MDR?

Quality Management System (QMS) Requirements

  • Is there a documented QMS?

  • 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.)

  • 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)

  • Is there a training procedure that describes a documented training program to ensure personnel are competent in performing their respective duties?

  • Is there a purchasing control procedure to qualify suppliers including your transportation partners?

  • Is there a complaint handling procedure to ensure appropriate economic operators such as Competent Authorities, Authorized Representatives and Importers are notified promptly?

  • Is there an investigation procedure to log complaints and investigate complaints related to distribution?

  • Is there an adverse event reporting procedure to ensure appropriate supply chain partners such as Competent Authorities, Authorized Representatives and Importers are notified promptly?

  • 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?

  • 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

  • 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?

  • Is there an inventory control procedure that ensures stock rotations are conducted AND First In First Out (FIFO)?

  • 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)

  • 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)?

  • 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?

  • Is there a procedure that describes handling of customer orders including pick, pack and ship?

  • Are there distribution records that maintain traceability of medical devices sold to customer?

  • Is there a process control to ensure the product transportation conditions comply with conditions set by the manufacturer?

  • Is there a Disaster Recovery Plan and/or Business Contingency Plan in place?

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.