Quality Assurance Policy

For full QAP, please contact SurgiShop at Sales@SurgiShop.com

Mission Statement

SurgiShop implements and establishes progressive policies that protect SurgiShop’s organization and clientele with the reassurance of receiving quality knowledge, service, and care. As environmentally conscious redistributors of manufacturer “PMDs” (Prescription Medical Devices) to industry proprietors such as: large hospital groups, institutions, and surgical facilities. SurgiShop operates above the industry standard to ensure the integrity of its products by purchasing solely through vetted suppliers: hospital & surgery centers as well as medical device distributors. Ultimately allowing SurgiShop to provide reliable & strategic supply chain solutions accompanied by the best prices in the industry.

Scope

Provide a detailed and transparent layout of the various protocols and processes that comprise SurgiShop’s Quality Assurance Policy.

Vendor Agreement (Form available at request)

All of SurgiShop’s suppliers must adhere to SurgiShop’s Vendor Agreement form, which outlines FDA and SurgiShop quality assurance requirements. The Vendor Agreement form dictates the terms of pricing, purchase orders, insurance, standards of goods, logistics, product recalls alongside the typical standard formal terms and conditions necessary to conduct compliant transactions. (Copy available upon request)

Quality Inspection Process

All of SurgiShop’s inbound products are subjected to SurgiShop’s mandatory 12-point Quality Assurance inbounding protocol. If any products fail to meet SurgiShop standards or FDA standards, products are deemed non-compliant and immediately separated. Furthermore, all non-compliant products are documented, logged, and discarded/destroyed.after goods are returned to SurgiShop’s warehouse at no cost to the buyer.

Listed below are tenants of SurgiShop’s Inbounding

Quality Assurance Protocol per SurgiShop’s Quality Control (QC) team:

Authentication

SurgiShop’s Warehouse Product Specialists are responsible for inspecting each inbound PMD to ensure authenticity and that products are in the correct packaging. SurgiShop then matches all primary packaging with any secondary packaging. Lastly, the seals of the packaging are also verified to ensure all the contents are fully included and intact.

Sterility

All products received by SurgiShop are to be OEM sealed, sterile, and long-dated. All inbound PMDs are individually analyzed using tools such as light tables and imaging enhancement to spot any potential sterility issues inflicting any products. Any potential punctures or holes are analyzed under a digital microscope on-site to ensure sterility and quality assurance guarantees have not been compromised.  All PMDs with sterility issues are marked as non-compliant and removed from the inventory value stream.

Expiration

SurgiShop does not take in, or ship out, any expired items under any circumstances. Generally, all inbounding products must have a shelf life of over SIX months in order to be admitted to SurgiShop inventory. Furthermore, if a product is less than ONE year until expiration, an explicit message will be sent out to the customer for purchase approval.

Fraudulent Items

Any items received and identified as fraudulent are either disposed of or returned to the supplier. The supplier is notified and placed on a 1-year probationary period, in which case any other incident within that year would result in termination of business with the supplier. If there is concern of fraudulence, SurgiShop will exhaust all resources, including contacting the OEM to ensure a product’s legitimacy before allowing it to pass SurgiShop’s quality department.

Storage

All products are required to be stored below 72 degrees Fahrenheit and 50% humidity on a 24/7/365 basis. SurgiShop has an active climate monitoring system that provides climate alerts and keeps historical data on all temperature/humidity fluctuations.

Bio-components & Temperature Indicators

SurgiShop uses a combination of OEM/Historical product data and temperature indicators to verify all bio components of the PMD are in OEM sealed condition. If an indicator has been activated, that product is deemed non-compliant and removed from the product value stream.

Furthermore, SurgiShop will not ship bio-component products to its customers slower than FedEx Standard Overnight; unless requested and approved by the customer.

Recall

To assure all inbounded PMDs are free of recall, SurgiShop Warehouse Specialists cross-references any inbounding PMD data against the FDA recall database to assure that no products are flagged. If recalled products have been received, the products are removed from all value streams. Customers who have received recalled products from SurgiShop will be contacted immediately by SurgiShop with the details and instructions administered by the FDA and/or OEM regarding the process for the recall.

Recall Protocol

• SurgiShop will update all data files regarding FDA recall management

• Instructions are sent to all parties affected by the recall

• Administrating real-time physical check of any/all existing potential recall products in inventory

• Recalled reference number(s)/product(s) becomes auto-flagged for 5 years in both inbound/outbound checks

•SurgiShop will notify any/all suppliers who have provided recalled products. Recall data is collected from the FDA link below to verify the legitimacy and importance of each recall.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

Repackaging

SurgiShop will only accept untampered OEM quality PMDs and thus will not process or accept repackaged or re-sterilized products.

Record Keeping

Data is actively recorded and stored on the following processes:

  • Inbound (supplier, product, LOT, dates)
  • Outbound (customer, product, LOT, dates)
  • Quality Reports (inbound)
  • Recalls Reports (active, terminated)
  • Product Image Archive
  • Inventoried Product Expiration Dates
  • Climate Control Reports (Inventory)
  • Temperature Requirements ( Inventory)

Data files are stored via SurgiShop’s private data storage to assure the privacy of SurgiShop’s customers. SurgiShop guarantees that SurgiShop will not solicit, sell, or share any information about any client unless explicitly authorized/agreed upon by both parties.

Inbound/Outbound Process Map

Rejection Process Map