Control of Labels

Purpose

• The purpose of this SOP is to describe the procedure for issuance and control of quality status labels.

Scope

• All the packing labels used for defining the quality status of materials at every stage.

Reference(S) & Attachment(S)

• References
• ISO 15378:2017
• Attachments: Nil

Responsibility

• QC Person
• To execute the pasting of labels.
• QA Head
• To issue and control the labels.

Distribution

• Quality Assurance
• Quality Control
• Production

Definition(S) & Abbreviation(S)

• Definitions
• Nil
• Abbreviations
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure

Procedure

• Once the raw material is received by Stores, it is to be quarantined by Stores and the GRN information is pasted on to the material. Then the Quality department does the sampling as per their defined sampling plan and puts a “Sampled” label on the roll / container from which the sample is drawn.
• Once the material is cleared by the Quality department, the material is reidentified with a “QC PASSED” label (SIPL/QCS/002/F10/00). The information as defined above will remain the same.
• If the material is under hold, then a “HOLD” label (SIPL/QCS/002/F11/00) is used along with the reason and date of hold. The signature of the person who issued this label is also available.
• If the material is rejected at any stage of product realization, then the label “REJECTED” (SIPL/QCS/002/F12/00) is used. The date and signature of the person responsible will be mentioned on the label along with the reason for rejection.
• If the quality of in-process or final product is accepted by QC, then “QC PASSED” (SIPL/QCS/002/F10/00) is used by Quality again.
• It is ensured that material is used only if found with a “QC PASSED” label.
• The custodian of all status labels is the QA Head.

Revision History

Revision No.

Effective Date

CC No.

Details of revision: New SOP