by - OBJECTIVE
To lay down the procedure for Handling of Online Rejected Raw and Packing Materials.
2. SCOPE
This SOP is applicable to all Online Rejected Raw and Packing Materials.
3. RESPONSIBILITY
| Officer or Nominee of Production / Stores | : | To initiate the online rejection note |
| QC Chemist | : | To check the material |
| Head Purchase | : | To inform the supplier and get the CAPA |
| Head QA or Nominee | : | To certify online rejection and ensure the compliance |
4. ACCOUNTABILITY
| Concerned Department Head | : | For compliance of SOP |
5. PROCEDURE
5.1 If any abnormal observation or deficiency is detected in the raw or packaging materials during storage, dispensing or processing of any batch, the same shall be informed through “Online Rejection Note”. Refer flow chart .
5.2 Concerned department officer/nominee shall initiate the “Online Rejection Note” with verification of concerned department Head.
5.3 QA shall allot the number to “Online Rejection Note”.
5.4 The numbering of “Online Rejection Note” shall allot as OLR/YY/NNN, Where OLR is indicates for online rejection note, YY is last two numerals of year and NNN is indicates for serial number, starting from 001 in each calendar year.
5.5 Based on the nature of the problem, QA shall verify the usability of the material after evaluation. In case the material is found acceptable to use, the same shall be conveyed to user through “Online Rejection Note” for further usage. QA shall clearly specifies the need for any additional checks/sorting or precautions as required.
5.6 The numbering of “Online Rejection Note” shall allot as OLR/YY/NNN, Where OLR is indicates for online rejection note, YY is last two numerals of year and NNN is indicates for serial number, starting from 001 in each calendar year.
5.7 Based on the nature of the problem, QA shall verify the usability of the material after evaluation. In case the material is found acceptable to use, the same shall be conveyed to user through “Online Rejection Note” for further usage. QA shall clearly specifies the need for any additional checks/sorting or precautions as required.
5.8 If the material is unacceptable to use after evaluation, the material shall be identified and segregated. QA shall affix “Hold Label” on the segregated material and processed portion of the batch if any.
5.9 Based on the initial evaluation, Head – QA shall investigate the problem in coordination with production, QC, purchase if required and take up the matter with vendor.
5.10 QC shall check the rejected material and verification shall be done for stock quantity if required based on the Head-QA comments.
5.11 QC shall perform if any testing’s required for rejected or stock material as per Head – QA comments.
5.12 After verification Head – QC / Designee shall put his/her comments in “Online Rejection Note”.
5.13 Based on the investigation, the material shall be rejected or approved as appropriate with approval of Head-QA / Designee.
5.14 QC shall reject in ECOM for the quantity available in the stock other than online rejection of particular batch or lot if required.
5.15 In case of online rejected materials, Officer/nominee production shall handover the material to stores with online rejection note.
5.16 Store Officer/nominee shall shift the rejected material to rejected storage area in stores in presence of QA and forward the “Online Rejection Note” to QA. Enter the details in log.
5.17 Once online rejection note is received, printed packaging materials shall be destroyed by Stores. Necessary documentation shall be maintained. In case of raw materials and unprinted packaging materials, the material shall be returned to the manufacturer/supplier.
5.18 Head-QA shall forward a copy of “Online Rejection Note” to Head-Purchase, Head-stores and Head-Accounts.
5.19 Head-QA upon receipt of the corrective and preventive actions and investigation details from the manufacturer or supplier shall enter the same in corrective actions column.
5.20 Head-QA shall evaluate the effectiveness of the corrections taken by vendor and finally dispose the “Online Rejection Note”.
6. TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7. DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8. ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1. | NA | NA | NA |
9. REFERENCES
In-house
10. ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
