Operating Procedures

Quick Box

Fulfillment Service Levels & Standard Operating Procedures

FIRST OPPS, INC. DBA QUICK-BOX

11551 E. 45th Avenue,

Unit C, Denver, CO 80239 USA

Quick-Box

Fulfillment Standard Operating Procedures

Table of Contents

  • OPS – 1 Order Transfer and Order Processing ………………………………………………………………….5
  • Order Transmission …………………………………………………………………………………………………….…5
  • Printing and Sorting Invoices ……………………………………………………………………………………….…5
  • Determining Postage ……………………………………………………………………………………………………..5
  • Reship and Exchange Shipments …………………………………………………………………………………….5
    • OPS – 2 Fulfillment Reporting and Status Updates …………………………………………………………..7
    • Fulfillment Summary ……………………………………………………………………………………………………..7
    • Order Status Updates ……………………………………………………………………………………………………..7
      • OPS – 3 Large Order Verification …………………………………………………………………………………….8
      • Procedure ……………………………………………………………………………………………………………………..8
      • OPS – 4 Shipping, Receiving and Inventory Procedures …………………………………………………….8
      • Receiving at Quick-Box …………………………………………………………………………………………………..9
      • Shipping at Quick-Box ……………………………………………………………………………………………………9
      • Inventory ………………………………………………………………………………………………………………………10
      • OPS – 5 Processing Customer Returns (Logging) ………………………………………………………………11
      • Processing ……………………………………………………………………………………………………………………..11
      • OPS – 6 Processing Customer Returns (Keying) ……………………………………………………………….12
      • Access to Returns …………………………………………………………………………………………………………..12
      • Log Sheets …………………………………………………………………………………………………………………….12
      • Refunding Customer Orders ……………………………………………………………………………………………12
      • Exchange Credit …………………………………………………………………………………………………………….12
      • OPS – 7 Provisions for Re-Using Returned Products (Quality Control) ……………………………….13
      • Procedure ……………………………………………………………………………………………………………………..13
      • Recall for Suspect Products …………………………………………………………………………………………….13
      • OPS – 8 Recall Procedures ……………………………………………………………………………………………..14
      • Recall Notification …………………………………………………………………………………………………………14
      • Recall Strategy ………………………………………………………………………………………………………………14
      • Termination of Product Recall ………………………………………………………………………………………..14
      • Product Destruction ……………………………………………………………………………………………………….14
      • OPS – 9 Facilities Maintenance and Cleanliness ……………………………………………………………….15
      • Monitoring and Reporting ………………………………………………………………………………………………15
      • Personnel ………………………………………………………………………………………………………………………16
      • PERS – 1 Accessibility and Employee Hygienic Practices …………………………………………………..16
      • Quick-Box Facility Hours of Operation …………………………………………………………………………….16
      • Accessibility …………………………………………………………………………………………………………………..16
      • Employee’s and Employee Hygienic Practices …………………………………………………………………..16
      • Personnel Qualifications …………………………………………………………………………………………………17
      • Supervisor Qualifications ………………………………………………………………………………………………..17
      • PERS – 2 Employee Access to UltraCart ………………………………………………………………………….18
      • Full Access …………………………………………………………………………………………………………………….18
      • Partial Access ………………………………………………………………………………………………………………..18
      • Customer Service Access ………………………………………………………………………………………………..18
      • Granting Access …………………………………………………………………………………………………………….19
      • Removing Access/Change of Access …………………………………………………………………………………19
      • PERS – 3 Manager, Supervisor, and Quality Control Responsibilities …………………………………20
      • Fulfillment Management ………………………………………………………………………………………………..20
      • Supervisor Responsibilities …………………………………………………………………………………………….20
      • Quality Control Responsibilities ………………………………………………………………………………………20
      • Communications ……………………………………………………………………………………………………………21
      • COM – 1 Shipping Contact Information & Shipping Requests ……………………………………………21
      • Warehouse Contact Information ……………………………………………………………………………………..21
      • Shipping Requests ………………………………………………………………………………………………………….21
      • Fulfillment Center Contact ……………………………………………………………………………………………..21
      • COM – 2 Non-Disclosure Agreement & Client Contact Disclosure ………………………………………22
      • Non-Disclosure ………………………………………………………………………………………………………………22
      • Client Contact Disclosure ………………………………………………………………………………………………..22
      • COM – 3 New Product SKU’s and PPID Information …………………………………………………………23
      • Creating New Products …………………………………………………………………………………………………..23
      • Creating and Updating Collateral Items …………………………………………………………………………………… 23
      • Additional Information for Inventory Items ………………………………………………………………………………… 23
      • Documentation …………………………………………………………………………………………………………………….. 23
      • COM – 4 Order of Escalation ………………………………………………………………………………………….. 24
      • Quick-Box Fulfillment Operational Structure …………………………………………………………………………….. 24
      • Client Operational Structure …………………………………………………………………………………………………… 24
      • Communication between Companies ……………………………………………………………………………………… 24
      • Documentation ………………………………………………………………………………………………….. 25
      • DOC – 1 FDA & CDPHE Documentation ……………………………………………………………………………. 25
      • Compliance …………………………………………………………………………………………………………………………. 25
      • Records ………………………………………………………………………………………………………………………………. 25
      • DOC – 2 Customer Complaints and Adverse Reaction Reporting ………………………………………….. 27
      • Customer Complaints ……………………………………………………………………………………………………………. 27
      • Complaint Review ………………………………………………………………………………………………………………… 27
      • Mandatory Med Watch Reporting …………………………………………………………………………………………… 28
      • Voluntary Med Watch Reporting …………………………………………………………………………………………….. 28
      • Documentation of Med Watch Reporting …………………………………………………………………………………. 28
      • DOC – 3 Chain of Custody ………………………….…………………………………………………………………….. 29
      • Sample Collection ………………………………………………………………………………………………………………… 29
      • Sample Identification …………………………………………………………………………………………………………….. 29
      • Chain of Custody or Possession …………………………………………………………………………………………….. 30
      • Change of Possession ………………………………………………………………………………………………………….. 30

Operations

OPS – 1 Order Transfer and Order Processing

Purpose: To ensure the proper procdures and processes are taken to transmit and receive orders in the “Quick-Box Warehouse Management System”.

Order Transmission

      • A. Order files will be collected and transferred to the shipping department via open API, FTP access, or order file uploads by Client or connections between systems.
      • B. Orders that are visible in the shipping department will be considered valid and will be processed.

Printing and Sorting Invoices

      • C. Fulfillment employees will print and sort all transmitted orders daily.
      • D. Standard print cut off times for all carrier options is 1:00 PM MST. For special considerations or specific client options please contact the Operations Manager.
      • E. Invoices shall be prioritized for packing as requested by the Operations Manager. Special accommodations may be made for specific shipments by contacting the Operations Manager or Fulfillment Supervisor following the Quick-Box order of escalation model (See SOP COM-4).
      • F. All shipment methods submitted will be followed unless otherwise specified by Client in writing. Orders submitted without an associated carrier option will not be shipped until the order has been updated and approved by Client.

Determining Postage

      • G. Postage costs are based on the current postage rates from UPS, UPS Mail Innovations, USPS, Fed- Ex, XPO, etc. Information regarding the current rates may be obtained by contacting the Operations Manager or Client Account Manager.
      • H. Per the Client Fulfillment Agreement, Section 4 Pricing of Fulfillment Services, Sub-Part f; Client agrees to pay for shipping postage charges per the agreements with its associated carriers. Quick- Box will suspend services if Client’s shipping account is deactivated or discontinued by Client, Quick- Box, or the carrier. The carrier accounts and postage must be supplied and maintained by the client.
        Quick-Box fulfillment will not ship orders without valid and active shipper accounts maintained by Client.
      • I. Delivery confirmation or tracking information will be uploaded to the Warehouse Management System after orders have been processed and the end of day operation has been performed.

Reship and Exchange Shipments

      • J. Reship and exchange shipments shall be processed through the warehouse management system to account for all inventory movement in or out of the facility.
      • K. Orders submitted to Quick-Box as a reship or exchange shipment must be documented in the following methods:
        • a. An email notification must be sent to the Operations Manager or Fulfillment Supervisor that includes the associated order ID, reason for reship, and preferred shipping method.
        • b. Reship orders must be processed through the warehouse management system by an approved, qualified, and trained individual. Tracking must be added to the shipment in the tracking link field.
        • c. Client is responsible for all account and postage charges associated to a reship or exchange unless previously communicated and approved in writing by the Operations and Billing Departments at Quick-Box Consulting.

OPS – 2 Fulfillment Reporting and Status Updates

Purpose: To ensure all reports are updated and available for operational review, and allow visibility of current
inventory status at Quick-Box Facility.

Fulfillment Console
        • A. The client fulfillment console is available at:
          https://secure-wms.com/PresentationTier/loginform.aspx?3pl=%7B7a1060e7-72e2-4aac-93ed-9f97d43d9f45%7D
        • B. Specific information that must be updated:
          • a. Total Orders Processed
          • b. Returns Processed
          • c. Products/ Packaging Received
          • d. Inventory Adjustments
          • e. Total Charges Billed on Each Transaction
        • C. The Client billing summary will be reviewed weekly by the Quick-Box billing department for invoicing.
Order Status Updates
      • D. Orders in the Quick-Box Fulfillment Console will change to a different status as the orders are processed or updated the following are examples of the current order status updates and a brief explanation of the status:
        • a. Status Open – Order has been received and is now showing in the shipping department. A packing slip or pick ticket may be printed and the order shipped.
        • b. Status Closed – The order has been processed and the shipment charges have been confirmed.
        • c. Inventory Allocation Sufficient – A packing slip has been printed and the product inventory has been assigned. The order will move to closed after all items have been verified and the shipment is confirmed.
        • d. Inventory Allocation Over – The order has been received but is able to be shipped due to current product inventory. Order will be released to the shipping department for processing.
        • e. Confirmed – The transaction has been fully processed or a carrier closeout has been
          completed and the order will be picked up by the carrier.
        • f. Canceled – The transaction has been stopped. Notes should be placed in the warehouse instructions section to notify the client why a transaction was canceled
      • E. Exceptions to these status updates should be processed according to the transaction process.
        Questions regarding any exception should be directed to the Operations Manager or the Quick-Box
        Account Manager assigned to Client.

OPS – 3 Large Order Verification

Purpose: To ensure orders outside the normal scope of sales are verified by Client prior to order shipment.

Procedure
      • A. As packing slips are generated and sorted in the fulfillment center, employees shall pay close attention to the order contents. Packing slips should not be included within the actual shipment.
      • B. If an order falls outside the normal scope of sales or seems to be missing an item that is normally required, it shall be brought to the attention of the Fulfillment Supervisor.
      • C. The Fulfillment Supervisor must attempt to obtain documented permission from the client prior to allowing the order to be shipped.
      • D. Un-authorized shipments must be canceled by the Fulfillment Supervisor.
      • E. Any attempt to verify a large order, as well as the outcome of the communications, must be documented in the warehouse notes section.

OPS – 4 Shipping, Receiving and Inventory Procedures

Purpose: To ensure all incoming shipments received and packages shipped are processed correctly and that documentation of the process is maintained. To ensure that the product integrity is maintained during all processes at Quick-Box Fulfillment Center.

Receiving at Quick-Box
      • A. All product/packaging shipments made to Quick-Box fulfillment Facility must be generated into a shipping manifest or purchase order prior to the shipment arriving at the facility.
      • B. Incoming shipments must be disclosed to Quick-Box prior the shipment arrival to ensure a timely response from the receiving team.
      • C. Vendors/Manufacturers must be notified of the required information of a shipment prior to transferring to the fulfillment facility. The following information must be included on the packing slip:
        • a. Product Name
        • b. Product Lot Number(s) (If applicable)
        • c. Product Expiration Date(s) (If applicable)
        • d. Quantity of each product shipped
        • e. Purchase Order Number(s)
        • f. Product SKU
      • D. If a manifest or purchase order is not submitted to the Warehouse Management Consol prior to the shipment arrival at the facility, the receiving process may be delayed until a manifest is received from the client.
      • E. Quick-Box receiving employees will stage all received products in a designated receiving area.
        • a. Products will be checked in by case quantity, case weight, or by actual product count depending upon the type of product.
        • b. Shipments received by case quantity will be documented and a receiving notification will be sent to the client. Further inventory processes or quality assurance regarding these counts will be billed to the client at the current warehouse labor fees.
        • c. Quick-Box employees shall enter all specified information into the Warehouse Management Console and receiving log. Examples of specified information are as follows:
          • i. Product Lot
          • ii. Product Expiration
          • iii. Product Identification
          • iv. Product Quantity Received
      • F. Products received on any manifest will not be available inventory until the entire receiving process has been completed. Incoming shipments must be received, put away, and the manifest must be reviewed and confirmed in the Warehouse Management Console by a Fulfillment Supervisor before the inventory will be made available for shipping.
      • G. Receiving Billing
        • a. All charges associated to product receiving shall be made available on the Warehouse Management Console after receiving is complete.
        • b. Charges are based on the current Client Scope of Work.
Shipping at Quick-Box
      • H. All orders printed at Quick-Box before the specified print cut off times will be shipped the same day unless an outstanding exception occurs which may be reviewed on a case by case basis.
        • a. If an order exception is generated prior to carrier pickup, the Fulfillment Supervisor will make 1 attempt to correct the shipment. If the shipment cannot be corrected for any reason the Fulfillment Supervisor will notify the client and the shipment will not be completed.
      • I. Shipping Methods
        • b. All packages will be shipped under the shipment code generated in the warehouse management console. It is the client’s responsibility to update shipping methods available to their customers prior to the shipment becoming available in the shipping department.
        • c. Shipments with postage generated will be shipped as they were processed unless documented communications were approved by the Fulfillment Supervisor and the client.
Inventory at Quick-Box
      • J. All product quantities, expiration dates and lot identification shall be monitored and maintained by the Quick-Box Fulfillment Team in as agreed by Converts and Quick-Box.
      • K. Any inventory discrepancies must be reported to the Fulfillment Supervisor for immediate review with the client.
      • L. Inventory of all stored products shall be completed no less than once annually, at the written request of Client. Additional inventory counts, cycle counts or audits are billed to Client at warehouse rates.
        • a. Any inventory discrepancies shall be reconciled following the procedures listed in the fulfillment Agreement.
        • b. Quick-Box Fulfillment employees shall follow all procedures listed in the Quick-Box Standard Operating Procedures during inventory process.
        • c. Products identified as “un-usable” for any reason will be brought directly to the Fulfillment Supervisor for review.
          • i. Products that are “un-usable” due to negligence will be reconciled following the terms in the Fulfillment Agreement
          • ii. Products that are “un-usable” not due to negligence will be reported to the client and
            disposed of per the client specifications following the report.

OPS – 5 Processing Customer Returns (Logging)

Purpose: To ensure that customer returns are completed in a documented and timely manner, and to ensure that all products received via returns at Quick-Box are handled as desired per the client specifications.

Processing
      • A. All returns shall be logged within 24 hours of the time that they arrive at the Facility.
      • B. All returned packages must be thoroughly documented on the returns logging report. The following
        information shall be captured:
      • a. Customer Name
      • b. Customer Order ID
      • c. Return Authorization Number or RA#
      • d. Product Name, Lot #, and Quantity Returned Sealed
      • e. Product Name, Lot #, and Quantity Returned Un-Sealed, Open, or Used
      • f. Refused or Returned to Sender
      • g. Comments (any relevant information such as: check enclosed, customer complaint enclosed, legal documentation enclosed, received package unsealed, etc.)
      • C. Any customer complaints, checks, money orders or legal documentation shall be given to an immediate supervisor. The supervisor will then process the information per Client and client policies.
      • Any correspondence made by a government agency shall be faxed or emailed to the client within 24 business hours of receipt. All other customer correspondence received by mail may be forwarded to the client weekly.
      • D. Any customer complaints or documentation regarding adverse reactions to product usage must be thoroughly documented on the returns logging sheet, and the documentation given to an immediate supervisor. The supervisor shall then follow Client procedures per Client specifications, and if none are available, then the supervisor shall contact Client immediatiely.
      • E. Any standard packing slips or non-pertinent documentation shall be properly discarded by disposing documents in a closed trash receptacle as well as any personal information shall be shredded.
      • F. If any product(s) enclosed are tampered with, opened, damaged, or used the products shall be discarded in a closed trash receptacle.
      • G. If any product(s) are unused, unopened, and clean and will be returned to stock as usable inventory they must first be sorted and quarantined, separating products by product SKU and lot number when applicable.
        • a. All bins of like lots may be returned to stock after provisions for quality control have been completed. (See SOP OPS – 7)
        • b. Products returned to regular inventory shall remain sorted by lot and the earliest expiring products shall be used prior to packing and shipping new products.
      • H. Any questions or concerns regarding this SOP must be brought to the attention of the Fulfillment Supervisor immediately.

OPS – 6 Processing Customer Returns (Keying)

Purpose: To ensure that customer returns are completed in a documented and timely manner.

Access to Returns
        • A. Designated employees must be properly trained to key returns back into the customer’s internal order management system.
        • B. Access rights to the internal system are granted per Client procedures. Please see your immediate supervisor to gain access to the internal management system.
Log Sheets
        • C. Employees shall access the internal system to reach the customer information.
        • D. Utilizing the returns logging sheets that have previously been completed, employees shall document all pertinent information regarding the customer return directly within the corresponding order. The following information must be documented whenever applicable:
          • a. Return Authorization Number or RA#
          • b. Product Name, Lot #, and Quantity Returned Sealed
          • c. Product Name, Lot #, and Quantity Returned Un-Sealed, Open, or Used
          • d. Refused or Returned to Sender
          • e. Comments (any relevant information such as: check enclosed, customer complaint enclosed, legal documentation enclosed, received package unsealed, etc.)
        • E. Employees shall maintain documentation of all returned products, usable or un-usable, and report this information to the Fulfillment Supervisor. This may also be completed by disseminating information via spreadsheet saved on a shared server network at Quick-Box facility.
        • F. Employees shall maintain documentation of the amount of returns logged, keyed, and the outcome of the customer return (refunded, not refunded)

Refunding Customer Orders

        • G. Employees shall follow the current return policy to identify if a customer is eligible for a refund. Please
          contact your immediate supervisor with any questions or concerns.
        • H. Refunds must be thoroughly documented in the internal order management system.
Exchange Credit
      • I. Employees shall follow the current policy to identify if a customer is eligible for an exchange credit.
      • J. Quick-Box Fulfillment employees will under no circumstances contact, or be asked to contact any of a clients customers directly or indirectly. Any communications required to be relayed to such customers must be completed by the client.
      • K. Exchanges and exchange credit must be thoroughly documented in the internal order management system.

OPS – 7 Provisions for Re-Using Returned Products (Quality Control)

Purpose: To ensure product safety and integrity prior to releasing products in returns quarantine to regular production. The following procedure must be followed by all employees when returning products received via returns package to regular stock.

Procedure
        • A. All products received from returns must be placed in the designated returns quarantine area until approved quality control personnel conduct a review and make a final disposition as to the product safety. Returned products will be released from quality control as requested by the Fulfillment

Supervisor.

        • B. All products received unsealed, opened, used, or are suspected to have been tampered with must be properly disposed in a closed container.
        • C. All products that are not suspected to have been damaged, used, or opened shall be inspected by qualified and trained quality control personnel.
          • a. Employees should inspect the integrity of the container, safety seals, and label.
          • b. Employees shall inspect the label for a valid lot number and ensure that the products are not within 1 month of the product expiration date, and in such case, they will not be used.
        • D. Documentation of all products returned to stock must be supplied to the Fulfillment Supervisor; this inventory will then be adjusted into the inventory via the internal inventory management system.
        • E. If the reason for a product being returned implicates that the batch or other batches may be causing adverse reactions, an internal investigation must be conducted following the procedures for the Current Good Manufacturing Practice. All packaging processes and holding processes must be inspected and cleared by the Fulfillment Supervisor and Operations personnel prior to the products being released from quarantine. If the products or the holding facility are not deemed safe, the products must not be removed from quarantine area.
        • F. Records of all processes must be maintained as required by FDA GMP 21 CFR Title 111. Of those provisions the following records shall be maintained within the facility:
          • a. Written procedures for fulfilling the requirements
          • b. Any material review and disposition decision on returned product
          • c. The results of any testing or examination conducted to determine compliance with product specifications.
          • d. Documentation of the re-evaluation by quality control personnel of any supplement that it reprocessed, and the determination by quality control personnel of whether the re-processed product meets product specifications.

Recall for Suspect Products

      • G. Recall procedures must be outlined and maintained per Client policies.
      • H. Any product(s) suspected to be contaminated or suspect of generating an adverse reaction shall be
        quarantined as noted in Client policies.

OPS – 8 Recall Procedures

Purpose: To ensure Client preparedness and documentation is maintained relating to product recalls and to ensure consumer safety and notification if a product is deemed to be un-usable.

Recall Notification
        • A. Notification of a credible or consistent adverse reaction shall be given to the Fulfillment Supervisor and Client per the order of escalation procedures listed in SOP COM-4
        • B. Customers will be notified via telephone, certified mail, or email by the client’s customer service personnel. Customers will be asked to return the products listed under the appropriate lot number in
          question
        • C. The manufacturer will be notified and a date range of the product production shall be acquired.
        • D. The Client management team shall notify all regulatory agencies.
        • E. Notification of an adverse reaction will be given to the regulatory agencies utilizing the appropriate
          watch program. Notification must be received by the regulatory agency within 15 days of the event report
Recall Strategy
        • F. Fulfillment personnel shall pull all products under the specified lot number and quarantine the products. Returns personnel shall be notified as well, and identify all incoming returns products and place it in the appropriate quarantine area.
        • G. Lots produced directly before and after the lot in question shall also be pulled for quarantine if the product was produced in the same manufacturer facility.
        • H. If deemed necessary, the Fulfillment Supervisor shall send product samples to a contracted laboratory testing facility for product testing. Procedures shall be followed as specified in SOP DOC-3
Termination of Product Recall
        • I. A recall will be terminated when Client and the recalling firms are in agreement that the product subject to the recall has been deemed safe and the proper disposition or correction has been made.
Product Destruction
      • J. Products determined to be out of specifications or unsafe shall be quarantined until the disposition decision is documented.
      • K. items shall be destroyed as instructed by regulatory agencies, and Client management. Product destruction must be documented and approved by Client, the regulatory agencies, and Fulfillment Center Management.

OPS – 9 Facilities Maintenance and Cleanliness

Purpose: To ensure product quality by maintaining the warehouse facility.

Monitoring and Reporting
      • A. Facility maintenance shall be monitored by Fulfillment Center employees and management staff. Any repairs to facility support systems will be completed by the Quick-Box staff or contracted private companies. The following are considered to be facility support systems:
        • a. HVAC
        • b. Water heater and water lines
        • c. Sewage lines and drainage
        • d. Facility Electrical systems
      • B. Maintenance to the building itself shall also be maintained by the fulfillment center or contracted private companies. For the purposes of this procedure, the following is considered building maintenance:
        • a. Damage to structure, exterior walls, load bearing walls, roofing structure, building foundation, parking areas, garage doors, windows, and egress doorways/doors.
      • C. Maintenance to exterior portions of the building such as landscaping is to be completed by Fulfillment
        Center personnel or private contracted companies. Basic exterior maintenance includes:

        • a. Cutting grass and removing all weeds, as well as placing waste into proper trash receptacles.
        • b. Tree/Bush Trimming
        • c. Inspecting areas not readily visible such as near sewer drains and behind landscape objects for pest control purposes.
      • D. Fulfillment Center employees shall complete the following duties as requested by Quick-Box
        management:

        • a. Sweep and mop all floor surfaces in the warehouse
        • b. Inspect areas behind pallets, desks, and other surfaces not readily visible, for pest control purposes.
        • c. Sanitize table tops where products are packed and returns are logged.
        • d. Ensure proper disposal of all expired, opened, or un-usable products.
        • e. Inspect/replace pest control apparatus and report any pest activities.

Personnel

PERS – 1 Accessibility and Employee Hygienic Practices

Purpose: To ensure that products owned by clients are accessible during normal business hours at the Quick-Box facility, and to ensure that all employees are qualified and trained in proper storage and handling of Dietary Supplement Products.

Quick-Box Facility Hours of Operation
      • A. Normal business hours for Quick-Box facilities allow clients to access the building between the hours of 7:30AM to 4:30PM MST.
      • B. Office hours may vary depending upon the availability of the Quick-Box Account Manager.
      • C. Saturday and Sunday the warehouse and offices are closed.
      • D. Hours of operation during holidays may vary, please contact an account manager for the current holiday schedule.
Accessibility
        • E. The Fulfillment facilities shall be accessible to office employees of Quick-Box and Quick-Box clients during normal business hours only.
        • F. Operations within the Fulfillment facility may continue outside of the normal business hours with prior approval from the Operations Manager.
        • G. Access to the fulfillment center by client personnel should be limited to management staff only.
        • H. Quick-Box maintains a secure facility by use of electronic security systems, and full time employed staff.
          • a. All clients and guests entering the facility must accompanied by a Quick-Box full time staff member while within the facility.
          • b. All clients must check out of the facility prior to leaving Employees and Employee Hygienic Practices
        • I. In order to ensure the safety of employees and the products stored/distributed at the Quick-Box facility, all fulfillment center employees are required to pass an internal background investigation prior to beginning employment.
        • J. All warehouse and returns employees are required to complete orientation training, and read the full contents of the Quick-Box Standard Operating Procedures prior to beginning their regular position.
          • a. During this period employees shall review proper food handling and shipping procedures as
            required by the Food and Drug Administration (FDA).
        • K. Pursuant to the regulations outlined by the FDA, warehouse and returns personnel at Quick-Box Fulfillment facility are required to maintain the following hygienic practices:
          • a. Excluding employees from working in any operations that may result in microbial contamination of any food products or dietary supplements. Measures must be taken to ensure that any employee who might be a source of microbial contamination due to a health condition be excluded from areas holding dietary supplements and food products. Such contamination may occur of any material, dietary supplements, and contact surfaces used in the manufacture, packing, labeling, or holding of dietary supplements.
          • b. If acknowledgement by an employee, or supervisory observation, is shown to have, or appears to have, an illness infection, open lesion, or any other abnormal source of microbial contamination, that could result in microbial contamination of components, dietary supplements, or contact surfaces, employees shall not be allowed to handle dietary
            supplements or food products until the health condition no longer exists.
          • c. Employees shall be instructed to notify their supervisor(s) if they have or if there is a reasonable possibility that they have a health condition described that could result in microbial contamination of any dietary supplements or contact surfaces, the employee shall not be allowed to handle dietary supplements or food products.
        • L. Any employee in an operation during which adulteration of the component, dietary supplement, or contact surface, must use hygienic practices to the extent necessary to protect against such contamination of components, dietary supplements or contact surfaces. These hygienic practices include:
          • d. Maintaining adequate personal cleanliness.
          • e. Washing hands thoroughly and sanitizing if necessary before starting work and at any time when the hands may have become soiled or contaminated.
          • f. Not storing clothing or other personal belongings in areas where dietary supplements or any other contact surfaces are exposed or where contact surfaces are washed.
          • g. Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where dietary supplements, or any contact surfaces are exposed, and taking any other precautions necessary to protect against contamination of dietary supplements, or their contact surfaces, from microorganisms, filth, or any other extraneous materials, including perspiration, cosmetics, tobacco, chemicals, and medicines applied to the skin.
Personnel Qualifications
        • M. Quick-Box Fulfillment Center must maintain qualified employees who manufacture package, label, or hold dietary supplements.
          • a. The returns personnel at Quick-Box are responsible for quality control of returned products. Refer to SOP OPS – 7 for returned products specifications.
          • b. Each person engaged in manufacturing packing labeling, or in performing quality control operations, must have education, training, or experience to perform the person(s) assigned functions.
Supervisor Qualifications
      • N. Quick-Box management must assign qualified personnel to supervise the manufacturing, packing, labeling, or holding of dietary supplements or food products.
      • O. Each supervisor whom is utilized must be qualified by education, training, or experience to supervise.

PERS – 2 Employee Access to Management Systems

Purpose: To ensure employees have the proper access rights to the online management program and shipping program based on the employee(s) assigned duties.

Full Access
        • A. Employees may be granted full access rights based on their job description and title. Titles included
          having full access rights are included but not limited to the following:

          • a. CEO or Owner
          • b. Operations Manager
          • c. Operations Supervisor
          • d. Director of Finance and Analytics
          • e. Vice President of E-Commerce
          • f. System Administrator
          • g. Operations/IT Consultant
          • h. Project Manager/Account Manager
          • i. Fulfillment Supervisor
        • B. Full access rights can be limited to read only rights as dictated by Operational Personnel.
        • C. Full access rights do not give employees the right to change or update processes or information within the application. A request to change or add any information must be made by contacting the Fulfillment Supervisor.
Partial Access
      • D. Partial access shall be granted based on the employees’ job description and title. Partial access rights are specified within the employees’ personnel files at the Fulfillment Center. Titles with access to partial access rights include but are not limited to:
          • a. Accounting
          • b. Developer
          • c. Marketing
        Customer Service Access
        • E. Customer service personnel will be given access to information such as order status and delivery confirmation numbers. The following shall be accessible by customer service personnel:
          • a. Manage Shipments
          • b. Edit Shipments
          • c. View Shipment Details
          • d. Search for Shipments
        • F. Supervisors may require additional access to process reships or exchanges. The following rights shall be added to an account for supervisors in the call center and fulfillment center:
          • e. Create Shipments
        • G. Returns personnel in the call center and fulfillment center shall be specifically trained on the returns process for the Fulfillment Center. The following rights shall be added for properly trained personnel:
          • f. Manage Returns
          • g. Search for shipments
          • h. Export returns
          • i. View returns report
Granting Access
        • H. Access rights shall be granted to employees as deemed necessary by the Fulfillment Supervisor or Operations personnel. To gain access employees shall first contact their immediate supervisor and a request must then be sent by the supervisor to the Fulfillment Supervisor.
        • I. A request for access will then be given to the systems administrator for documentation
        • J. The systems administrator or Fulfillment Supervisor will set up the account and document all access rights given to the employee
Removing Access/Change of Access
      • K. Access to any fulfillment applications may be removed or changed at any time as deemed necessary or upon employee termination.
        • a. Notification of change must be given to the systems administrator.
        • b. Documentation of the change shall be maintained by the systems administrator and sent to the Fulfillment Supervisor upon request.

PERS – 3 Manager, Supervisor, and Quality Control Responsibilities

Purpose: To ensure proper training, knowledge, and experience is determined when assigning positions to Fulfillment Personnel.

Fulfillment Management
      • A. Ensure that all orders are fulfilled and shipped within the specified client shipping times, and ensure that all returns are logged within 24 hours of receiving.
      • B. Maintain integrity of client and fulfillment center policies throughout the facility C. Generate updates as necessary for all shipping methods available to Client as well as the knowledge of all products shipping capabilities in relation to postage, shipping, returns, and receiving.
      • D. Ensure all warehouse employees are trained and managed by monitoring the capabilities of each individual.
      • E. Maintain a process of rotating stock to ensure that products are shipped before the effective expiration date and lot assignments.
      • F. Maintain a process to ensure the integrity of the current product inventory.
Supervisor Responsibilities
      • G. Assist with ensuring all warehouse employees are trained and managed by monitoring the capabilities of each individual.
      • H. Maintain the integrity of the Fulfillment Center and client Client policies throughout the facility.
      • I. Assist with ensuring that all orders are fulfilled and shipped within the specified client shipping times, and ensure that all returns are logged within 24 hours of receiving.
Quality Control Responsibilities
      • J. Ensure that all returned products are staged in the proper area for inspection.
      • K. Inspect all returned products to ensure the integrity of the products, and supply documentation to the Fulfillment Supervisor relating to each product returned to inventory.
      • L. Properly place all products back into the assigned inventory area within a timely manner, as delegated by the Fulfillment Supervisor or Operations.

Communications

COM – 1 Shipping Contact Information & Shipping Requests

Purpose: To ensure that any request for shipping products and obtaining information about shipments are completed by properly trained and qualified employees, and to provide provisions necessary to allow employees to make requests for shipping to the proper personnel.

Warehouse Contact Information
      • A. For specific requests and documentation, contact the Operations Manager. Updated contact information is available on the Quick-Box shared network.
      • B. For contact information regarding vendors, shippers, suppliers, and regulatory authorities see the Fulfillment contact information available on the shared network. You may also contact the Fulfillment Supervisor.
Shipping Requests
      • C. For requests to ship or specific shipment information, access the Fulfillment Applications or contact the Fulfillment Supervisor.
      • D. Any requests to ship products that are not assigned to a specific order ID must be authorized by one of the following personnel prior to requesting the shipment from the Fulfillment Supervisor:
        • a. Client (Owner or CEO)
        • b. Director of Operations
        • c. Operations Manager
Fulfillment Center Contact
      • E. Contact with employees in the fulfillment center should be limited to the following:
        • a. Client (Owner or CEO)
        • b. Director of Operations
        • c. Operations Manager
        • d. Customer Service Managers
        • e. Development
        • f. Contracted employees with direct approval from the Owner, CEO, or Director of Operations

COM – 2 Non-Disclosure Agreement & Client Contact Disclosures

Purpose: To ensure that confidential and proprietary information regarding the Fulfillments Center and its clients are protected by all personnel within all facilities.

Non-Disclosure
      • A. The protection of confidential business information and trade secrets is vital to the interests and success of the Fulfillment Center and its clients. Such confidential information includes, but is not limited to the following:
        • a. Comprehensive Data
        • b. Financial Information
        • c. Marketing Strategies
        • d. Pending Projects and Proposals
        • e. Proprietary Production Processes
        • f. Personnel and Payroll Records
        • g. Conversations between and person(s) associates with either Client
        • h. Customer Information
      • B. All employees are required to sign a non-disclosure agreement as a condition of employment.
        • a. Employees who improperly use disclosed trade secrets or confidential business information will be subject to disciplinary action including termination of employment and legal action, even if they do not actually benefit from the disclosed information.
Client Contact Disclosure
      • C. Disclosure of Client contact information is limited to the operational personnel and supervisors. Employees should not share contact information other than that of their immediate supervisor.
        • a. The disclosures of Client information to any government and regulatory authorities shall be deemed necessary with due regard of Client policies.
        • b. Information should be relayed accurately and honestly, if at any time the person(s) disclosing information in uncertain of the correct answer, they must consult with their immediate supervisor.
        • c. All disclosure of Client information must be thoroughly documented as well as the information from the regulatory agency, and the representative of that firm.

COM – 3 New Product SKU’s and Product Information

Purpose: To ensure that all products added to the Fulfillment Application are tracked and logged properly, as well as to ensure that the Product information will match the product SKU.

Creating New Products
      • A. All new product and products kits must be entered into the Fulfillment Applications prior to the
        products arriving at the Fulfillment Facility.
      • B. Requests to add new products or kits must be given to the Client Account Manager or Fulfillment
Supervisor.
      • C. The following information is required for all new product SKU’s and kits:
        • a. Product Name
        • b. Distribution Client
        • c. Product ID (PPID or SKU)
        • d. UPC (If applicable)
        • e. Category (Supplements, Cosmetics, Inserts, Packaging, etc.)
        • f. Supplier
        • g. Weight
        • h. Any Applicable Inserts
      • D. After this information is obtained that item will be entered into the Fulfillment Application.
Creating and Updating Collateral Items
      • E. Collateral items, such as inserts and gift certificates, must be entered into the Fulfillment Applications as an inventoried SKU.
      • F. Clients must ensure that all collateral items are specified to the proper orders and that notification of which products will receive the collateral pieces is documented and sent to the Fulfillment console.
Additional Information for Inventory Items
      • G. Additional information such as cost of goods and additional inserts must be added to the Fulfillment console and updated each quarter per the Fulfillment Services Agreement.
Documentation
      • H. Any time a new product is entered into the Fulfillment Console, notification of the product SKU or PPID must be given to the Fulfillment Supervisor and Account Manager.
      • I. Clients should allow at least 1 full business day for the Fulfillment Supervisor or the account manager to enter and document new item SKU’s or PPID’s.

COM – 4 Order of Escalation

Purpose: To ensure the proper steps are taken in the chain of command, and that communication with the Fulfillment Center is appropriated to the correct department or personnel. This guideline allows for both the client and fulfillment employees to communicate in the most appropriate manner as well as provide support if any personnel are not available or responsive.

Quick-Box Fulfillment Operational Structure
      • A. The current Quick-Box fulfillment order of escalation is a follows:
        • a. Client Account Manager – Functions as the first point of contact regarding the following:
          • i. Product shipments and receiving
          • ii. Customer order issues (Exceptions within the Fulfillment Console)
          • iii. Product SKU’s and Bundle/Alias SKU’s (PPID’s)
          • iv. Inventory control, inventory adjustments, product lot/expiration assignments
          • v. Customer Returns Packages
          • vi. Login and Access Rights for the Fulfillment Console
          • vii. Updates and documentation of client and Fulfillment Center operations
          • viii. Fulfillment Agreements and Contracts
          • ix. Order uploads to the Fulfillment Console
          • x. Shipment Return Files to the Fulfillment Applications
          • xi. Fulfillment and Professional Service Charges and Arrangements
        • b. Operations Manager – Functions as the secondary point of contact regarding the issues appropriated in section (A) subpart (a) of this SOP. This responsible party should only be utilized if the Client Account Manager is not available or responsive. Please feel free to CC this position whenever you feel necessary or are requested to.
        • c. Director of Operations – Functions as an emergency contact regarding the issues appropriated in section (A) subpart (a) of this SOP. This responsible party should only be utilized if the positions listed above are not available or responsive. Please only email or carbon copy this position when specifically authorized or requested to do so.
      • B. Development – Specific personnel assigned to the development department may function as a secondary point of contact when identified and approved by the Fulfillment Supervisor. This responsible party will primarily function under the supervision of the Fulfillment Supervisor.
Client Operational Structure
      • C. The current client order of escalation regarding fulfillment operations is available on the Quick-Box shared network and must be updated whenever changes are made. Contact the Fulfillment Supervisor for further details.
Communication between Companies
      • D. Clients and Fulfillment Center personnel shall utilize this procedure as a guide to ensure the appropriate responsible parties are contacted
      • E. Additional personnel may be contacted or copied when appropriate and authorized by the Operations
        Manager.

Documentation

DOC – 1 FDA & CDPHE Documentation

Purpose: To ensure that all documentation required by the Food and Drug Administration (FDA), the regulatory authority of dietary supplements and food products is maintained properly by both the client and Fulfillment Center
Compliance

      • A. Documentation and records shall be maintained as originals or as copies. The following records shall
        be maintained per FDA regulations per CFR 21 Title 111:

        • a. Documentation of training, including the date of training, the type of training and the
          person(s) trained.
        • b. Documentation and maintenance of records of the written procedures for cleaning the physical plant and for pest control.
        • c. Written procedures for holding and distributing operations.
        • d. Records of product distribution
        • e. Any material review and disposition decision on a returned dietary supplement;
          • i. The results of any testing or examination conducted to determine compliance with product specifications established.
          • ii. Documentation of the re-evaluation by quality control personnel of any dietary supplement that is re-processed and the determination by quality control personnel of whether the re-processed dietary supplement meets the product specifications established.
          • iii. A written record of every product complaint that is received when the complaint is related to the current good manufacturing practice.
          • iv. The person who performs the requirements of this SOP must document, at the time of performance, that the requirement was performed.
        • f. The written record of any product complaint must include the following:
          • i. The name and description of the dietary supplement
          • ii. The batch, lot, or control number of the dietary supplement
          • iii. The date the complaint was received and the mane, address, or telephone number of the complainant if available
          • iv. The nature of the complaint including, if know, how the product was used
          • v. The reply to the complainant, if any
          • vi. Findings of the investigation and follow-up actions taken when an investigation is performed.
Records
      • B. All records required under 21 CFR Title 111, or copies of such records, must be readily available during the retention period for inspection and copying by the FDA when requested. All records required by the FDA shall be maintained for no less than 6 years, or as determined by the regulation stated.
        • a. Documentation of all customer complaints shall be maintained per this SOP and SOP DOC – 2 (Customer Complaints).

DOC – 2 Customer Complaints and Adverse Reaction Reporting

Purpose: To ensure proper procedures and requirements are fulfilled regarding the requirements made necessary by the CDPHE and the FDA. The following records and documentation shall be maintained per FDA/CDPHE regulations.

Customer Complaints

      • A. All customer complaints shall be documented thoroughly by customer service or returns personnel.
        Thorough documentation shall include:

        • a. All customer information available
        • b. Product Name
        • c. Product Expiration Date
        • d. Product Lot Number
        • e. Date that the customer complaint was received
        • f. Any accompanying documentation provided by the consumer
        • g. Customer complaints shall be documented by authorized personnel only. Authorized personnel shall be considered a supervisor or management authority working in the Fulfillment Center or customer service department.
Complaint Review
      • B. Complaints shall be reviewed by method of quality control. Qualified personnel shall research the seriousness or repetitive nature from the customer complaints, and if deemed necessary the products shall be removed from active inventory and a product recall activated following the procedures in SOP OPS – 8.
        • a. For the purposes of this procedure the following shall be considered quality control
          personnel:

          • i. Client or CEO
          • ii. Director of Operations
          • iii. Operations Manager
          • iv. Fulfillment Supervisor
      • C. Documentation of this procedure shall be maintained per SOP DOC – 1.
      • D. A written record of every product complaint that is related to the current Good Manufacturing Practice shall be documented. The person who performs the requirements of customer complaints must document, at the time of performance, that the requirement was performed.
      • E. Written records of product complaints must include:
        • b. The name and description of the dietary supplement
        • c. The batch, lot, or control number of the supplement if available
        • d. The date the complaint was received and the name, address, or telephone number of the complainant if available
        • e. The nature of the complaint, if known, and how the product was used
        • f. The reply to the complainant, if any
        • g. Findings of the investigation and follow-up action taken when an investigation is performed
      • F. Following the investigation of this procedure, the credibility of the customer complaint(s) shall be
        documented. If the complaint(s) are generating consistency, client management personnel will
        activate the product recall procedures specified in SOP OPS – 8.
Mandatory Med Watch Reporting
      • G. Any product complaints identifying that the product may have contributed to an adverse reaction must be reported to the FDA via the Med Watch program if the patient outcome results in the following:
        • a. Death – If the patient’s death is suspected as being a direct outcome of the adverse event.
        • b. Life Threatening – If the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient’s death.
        • c. Hospitalization – If admission to the hospital or prolongation of a hospital stay results because of the adverse event.
        • d. Disability – If the adverse event resulted in significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities, or quality of life.
        • e. Congenital Anomaly – If there are suspicions that the exposure to the product, prior to conception or during pregnancy, resulted in an adverse outcome in the child.
        • f. Requires intervention to prevent permanent impairment or damage – If suspected that the use of the product may result in a condition which required medical or surgical intervention to preclude permanent impairment or damage to the patient.
Voluntary Med Watch Reporting
      • H. Consumers, healthcare professionals, and patients may file a voluntary med watch report if the adverse event did not result in the patient outcomes listed above.
Documentation of Med Watch Reporting
      • I. Documentation must be maintained per the Med Watch Program as determined by the FDA.
      • J. Any reports of an adverse reaction must be received by the FDA within 15 days of the event report.
      • K. All customer complaints filed with Quick-Box Fulfillment Center or its clients regarding any supplement company resulting in the patient outcomes listed above must be reported to the FDA, unless the product complaint is that of a product not manufactured by or distributed by Quick-Box Fulfillment Center or its clients.
        • a. In the event that a product complaint is received by Quick-Box for a company that they are not affiliated with, the report will be given to the product manufacturer or distributor of the indicated company.
        • b. In the event that Quick-Box Fulfillment center is unable to contact the un-affiliated company, Quick-Box Fulfillment Center shall file a report of the complaint with the FDA and CDPHE.
      • L. All documentation of this procedure, any follow-up reports, and product dispositions must be
        maintained for no less than 6 years.

DOC – 3 Chain of Custody

Purpose: To establish a chain of custody and chronological documentation showing custody, control, transfer, analysis, and disposition of product testing.

Sample Collection

      • A. Sample collection is made when any valid product complaint is received.
        • a. These products are immediately identified and secured by a responsible party. They are to be locked and stored in a secure location.
        • b. This responsible party shall maintain all records and documentation of the received the shipment (Bill of Lading or Transfer Log) and the quantity received (Packing Slip)
Sample Identification
      • B. Sample numbers are assigned by the responsible party, this sample number will be used to identify the product throughout all documentation including computer entry, reports, data entry, and the chain of custody report.
        • a. Sample numbers for the products stored at Quick-Box Fulfillment Center shall be generated in the following format:
          • i. 2 Letters identifying the Company Name (2 Letter Abbreviation)
          • ii. 2 Letters identifying the product name (2 Letter Abbreviation)
          • iii. The month and year the product was received (MMYY)
          • iv. The product Lot number assigned by the manufacturer (Listed on bottle)
          • v. 1 Number, starting at 1, identifying which sample of the product was pulled from production. (An example would be if you pull 3 samples, the first sample is 1, second is 2, third is 3)
      • b. Sample Tags will be attached to the sample, written or typed shall be:
        • i. Sample Number
        • ii. Location Sample was pulled from (Facility Address)
        • iii. Dates of Samples
        • iv. Lot and expiration
        • v. The name of the employee documenting the sample collection
Chain of Custody or Possession
      • C. A chain of custody form shall be completed in full upon sample collection and follows every person
        involved in the chain of possession. It will include the following information:

        • a. Sample Number
        • b. Location Sample was pulled from (Facility Address)
        • c. Dates and times of sample collection
        • d. The name of the employee documenting the sample collection
        • e. Lot and expiration
Change of Possession
    • D. Any change of custody shall be documented
    • E. The person relinquishing the sample and the person receiving the sample must sign and date, time included, this shall also include documentation of any and all courier services used during transfer.
    • F. Samples will be logged into the lab or testing facility, checking to ensure that the tamper seals are intact and the proper signatures are present.

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