E-801

Return of Materials and Destruction of Non-Hazardous Waste Materials R11 -

Section E — Materials Management Revision 11 9 pages

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1.0 Purpose

This procedure defines the steps for return and controlled destruction of rejected, short dated,

obsolete, expired, or non-conforming materials and products.

2.0 Scope

This procedure applies to all raw materials, packaging components, printed packaging
components, in-process materials (WIP), and finished products at Ion Nutritional Labs that

require return or destruction. This procedure does not apply to the disposal of hazardous waste
materials.

3.0 Responsibility

3.1 It is the responsibility of the Department Manager/Supervisor or designee to report any
material that is non-conforming.

3.2 It is the responsibility of Inventory/Purchasing to confer with outside vendors for any
“Return to Vendor” and/or “Destruction” disposal requirements.

3.3 It is the responsibility of Sales (Account Managers) to obtain the required liability
information and acceptance of such liabilities from the customer (as applicable).

3.4 It is the responsibility of QC to ensure that non-conforming items are properly tagged.

3.5 It is the responsibility of all involved departments to follow this procedure.

4.0 Definitions

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4.1 QC — Quality Control

4.2 R&D - Research and Development

4.3 DC — Document Control

5.0 References

5.1 D-603, SOP, Hazardous Chemical Waste Disposal

5.2 C-502, SOP, Document Storage, Retention, and Destruction

5.3 E-801-F2, Vendor Return Form

6.0 Procedure

6.1 Waste Material Status

6.1.1 The Department Manager or designee will determine if a material requires an

electronic waste approval.

6.1.2 Waste materials that do not follow the electronic waste approval process are as
follows:

6.1.2.1 In-process — waste that is produced as part of the normal
manufacturing of a batch

6.1.2.2 R&D — waste that is generated during product research and
development

6.1.2.3 Stability samples — waste that is generated during stability testing or
when stability testing is discontinued or completed

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6.1.2.4 Reserve Samples — waste that is generated when reserve samples
exceed one year from expiration/best by date or three years from the

date of manufacture.

6.1.2.5 QC — finished product waste generated during testing

6.1.2.6 Dust Collector — waste that is produced from the internal and external
vacuum system in Compression and Encapsulation.

6.1.3 Examples of waste material that follow the waste approval process include but
are not limited to:

6.1.3.1 Any raw material, packaging component, in-process material, or
finished product that has been:

e Rejected

e Adulterated

e Damaged

e Expired

e Found Non-Conforming

6.1.4 Under no circumstances can a material classified as hazardous be disposed of

using this procedure. Classified hazardous waste materials need to be labeled

with a “Hazardous” placard and placed in Quarantine for processing and
disposal per SOP D-603 Hazardous Chemical Waste Disposal.

6.2 Completing the Waste Approval Process:

6.2.1 The initiator will access Microsoft Teams and select which material(s) are to be

wasted and submit for approval.

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File Path: Microsoft Teams > Document Requests > Expand Utilities > Workflows

6.2.2 Once the request has been electronically submitted it will route to the account

manager who will determine if the customer has any financial liabilities
associated with the material to be destroyed. If so, the account manager will

liaise with the customer to communicate the financial responsibility and
coordinate the repayment process externally. The account manager will attach

supporting documents and approve the request. The workflow will then be sent

to the Finance team.

6.2.3 The approval will then be submitted to the Finance department for review and

cost analyses as listed in Section IV Monetary Impact Information and
Destruction Approval. Finance will review the cost of the waste as well as the

type of inventory transaction needed for the waste and then submit to EHS
manager to then evaluate if material is hazardous or needs special handling

disposal. After this total cost is then sent to COO for approval.

6.2.4 If approval for destruction was not approved by the COO, reasoning and an

impact assessment will be done at this time.

6.2.5 If approved, the action will be given to QC and warehouse to pull material(s)

listed and verify batch numbers/lot numbers and total quantity/weight. The
materials will then be tagged with a “To Be Destroyed” tag.

6.2.5.1 If any containers are damaged, they will be repackaged at this time, if
applicable.

6.2.5.2 QC will verify the documentation. QC will then tag the materials in

question with a status tag “Hold for Disposition”.

6.2.5.3. Warehouse will ensure that the material is moved into the quarantine
area. If the quarantine area is full, an overflow area will be created and

must be approved by Quality before the material is moved.

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6.2.6 When the materials are ready to be physically destroyed, warehouse personnel
will locate the materials as listed and verify that all materials are accounted for.

6.2.6.1 The “Io Be Destroyed” tags will be removed from the pallets before
destruction and attached to the waste material form packet.

6.2.6.2 Ifthe material will be disposed of through the company’s disposal unit,
warehouse personnel will open all the containers and empty the

contents into waste bags, which are typically black garbage bags. Then
items can be discarded in the company disposal.

@ All printed packaging shall be destroyed by enclosed compactor

or incineration. If printed packaging or any other materials
designated for waste need to be taken to the incinerator a packing

list for those materials needs to be generated for traceability. This
does not apply to line-generated printed packaging waste. In-

process waste may be destroyed of in the company’s disposal
unit only after the art has been completely defaced.

6.2.6.3 Once the items are disposed of, Warehouse personnel will submit
completion to Finance.

6.2.6.4 Inventory Control will reconcile the inventory of the waste material at
this time.

6.2.6.5 Finance will update financial records as needed.

6.2.6.6 Once financial records have been updated by Finance a final

notification of completion is sent to the initiator.

6.3 Vendor Return

6.3.1 If it is determined that the material will be returned to the vendor, the initiator

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will complete Section I of Form E-801-F2 Vendor Return Form.

6.3.2 Once Section I has been completed, it will be forwarded to DC to assign a

material tracking number and document the number on the Vendor Return
Form. The information will also be documented in the electronic Return

Material Tracking Log, located here: F:\Doc Control Only\Forms and
Logs\Waste and Return to Vendor. The form will be forwarded to Shipping after

number assignment.

6.3.3 Material tracking numbers will be assigned using the following format:

6.3.3.1 V (for vendor return)

6.3.3.2 Two-digit year (YY) when the return was identified as needed

6.3.3.3. A three-digit sequential number beginning with 001 and allowing 999
per year if necessary.

6.3.3.4 Example: V-22-001 for the first vendor return occurrence of 2022.

Note: this sequential number will be shared with the waste material tracking

number assignment.

6.3.4 Shipping will review the material(s) listed on form E-801-F2 Vendor Return

Form and complete Section II Material Lot Information and Section III Return

Requirements. Once complete, the vendor return form will be forwarded to
Warehouse.

6.3.5 Warehouse will confirm the material listed on the form, tag the material with a
To Be Returned tag, and complete Section IV Material Confirmation. The form

will then be returned to Shipping to await pickup.

6.3.6 When the material has been picked up, Shipping will complete Section V

Shipping Information and return the form, along with all supporting

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documentation, to DC for routing to Inventory Control.

6.3.7 Inventory Control will reconcile the inventory of the returned material in

Batchmaster and complete Section VI Inventory Adjustment. Once complete,
the form will be returned to DC for routing to Finance.

6.3.8 Finance will ensure that all financial records are adjusted and complete Section
VI Financial Record Adjustment. The form will then be returned to DC for

closure.

6.3.9 Once the Vendor Return Form has been completed by Finance, it will be

returned to DC. DC will complete Section VIII Documentation Confirmation,
scan the completed packet, and file electronically in the following location:

F:\Doc Control Only\Forms and Logs\Waste and Return to Vendor.

6.3.10 All information will be logged in the electronic Vendor Return Tracking Log.

Note: [racking numbers assigned using one log and sequential numbering

system. Waste and return to vendor sequential numbers will be shared.
For example, the first form of the year is a waste form and will be

assigned the tracking number W-21-001. The second form of the year is
a vendor return form and will be assigned the tracking number V-21-

002.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/20/10 | New : 11/29/12 Changed format and title. Revised SOP to provide additional clarity and detail. : ; Z 06/17/13_ Reorganized the SOP for clarification. Revised forms. - - Realigned instructions on hazardous waste handling. Added : ieee rWeMfeFre nfcoer tmos Df-o6r0 h3a.z aRreddoeufsi nmede QC dtrsepspcoenksli bAildidtieeds .h aRzeamrodvouesd wuasset eo f isd ey nga label. Changed forms. Biennial review: Updated SOP format and responsibilities. Rewrote | - | - |
| 4 | 08/24/16 | for clarification. Removed form E-801-F3 and added electronic log reference. Changed forms. | 16-0774 | K. Burris |
| 5 | 11/29/17 | Revised flow of SOP to reflect complete rewrite of flow and | 17-1519 | K. Burris |

[SOP

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requirements as listed on the waste form E-801-F1. Changes
implemented for ease of use and verification at each step the correct
material is being identified and destroyed; added E-801-F3 and E-
801-F4 forms to ensure proper status identification of materials.
Scheduled review: updated entire procedure to reflect current
05/04/21 CC-21-0174 K. Burris
process. Removed forms F3 and F4.
01/11/22 Updated SOP to reflect correct practices and form flows. CC-22-0013 K. Burris
Added account manager responsibilities to determine liabilities for
08/26/22 waste materials. Clarified process throughout. Updated format and CC-22-0353 K. Burris
logo. Removed redundant and/or unnecessary steps.
Add place for inventory transaction type needed on form. Add this
01/30/23 requirement to procedure. Add material identification to vendor CC-23-0049 J. Murphy
return form.
To eliminate the waste material form and add in the new electronic
10 08/13/24 CC-24-0370 J. Murphy
waste approval process in teams
Add packing list creation for outside disposable for added
1] 08/04/25 CC-25-0311 J. Murphy
traceability. Updated Company Logo
8.0 Attachments
8.1 Attachment 1 — To be Returned tag
8.2 Attachment 2 — To Be Destroyed tag
ATTACHMENT 1 —- TO BE RETURNED

TO BE RETURNED

PALLET of

BY/DATE

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ATTACHMENT 2 —- TO BE DESTROYED

TO BE DESTROYED

PALLET of

BY/DATE