Standard operating procedure (sop). product identification and traceability.

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Standard Operating Procedure
Title: Product Identification and Traceability System Management

|Department: |Quality Management |Document no. |PIT-001 |  |
|Prepared by: |  |  |Date: |  |Supersedes: |  |
|Checked by: |  | |Date: |  |Date Issued: |  |
|Approved by: |  |  |Date: |  |Review Date: |  |

Document Owner
Quality Dept. Manager Mr.

Affected Parties
All manufacturing workforce

Purpose
The purpose of this SOP is to define the methodused for the identification of all contributing materials that could effect product quality used in the manufacture of product, and the final product, to ensure their full traceability.

Scope
Staffs are responsible for conducting required checking procedures as documented in the relevant SOPs pertaining to the activity being conducted.

Responsibility
It is the responsibility of the managementto ensure that the following procedures are adhered to and understood by all relevant personnel and the personnel follow State or local health department requirements.

Definitions
“Traceability is the ability to trace the history, application or location of that which is under consideration” Whole-chain insoles traceability is comprised of both “tracking” and “tracing”.
“Tracking” is theability to follow the path of a traceable item through the supply chain
as it moves between parties.
“Tracing” is the ability to identify the origin, attributes, or history of a particular traceable item located within the supply chain by reference to records held.
For true whole-chain traceability, product must be uniquely identified and recorded at each stage of its possession or transformationand these identifiers must be linked if they are to be of value in both traceability and day-to-day operations.

Instructions

1. Effective traceability requires standardizing the information that needs to be recorded through each step of the insoles production and distribution chain.

2. To ensure continuity in the flow of traceability information, each partner must pass on informationabout the identified lot or product group to the next partner in the chain.

3. It is imperative that the links between the lots and the logistical units (resulting from
a product transformation) are recorded. Within a company, the control of all these links and accurate recordkeeping make it possible to connect what has been received with what has been produced and/or shipped.

4. Implementingtraceability system the following steps must be conducted:
• Create a traceability project team within the organization.
• Conduct a Gap Analysis on existing traceability practices.
• Conduct a Business Case Analysis to quantify Return On Investment (ROI) resulting from enhanced traceability.
• Develop a strategic plan for enhancing traceability.
• Develop a migration pathfor incremental adoption of recommendations contained in this document.

5. Suppliers or distribution centers should mark cases with human-readable data including supplier name, product description and lot number. In the pilot studies, participants had proprietary codes for each of these elements; without human-readable labeling, there is no easy way to cross-reference this information.

6.Add the Lot Number to the box packaging containing a supplier ID. For our customers (retailers and dealers), addition of the lot number would improve traceability.

7. Shipment Identifier should augment or replace a buyer’s purchase order number in recall communications, as Shipment Identifier is defined to be unique. With the possible use of backorders, multiple products, multiple receiving...
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