SOP for Approval and Rejection of Raw Material and Packing Material
1.0 OBJECTIVE:
To describe the procedure for approving / rejecting of raw materials and packing materials.
2.0 SCOPE:
This Standard Operating Procedure (SOP) covers the procedure for approval / rejection of raw materials and packing materials.
3.0 RESPONSIBILITY:
QC Personnel:
1. Perform analysis, complete the analytical reports.
2. Prepare label of Approved and Rejected as per requirements.
Head QC/Designee/Section head:
1. Checking of analytical reports.
2. Approval of Certificate of Analysis (COA) by Head QC/designee.
QA Personnel:
1. Verify and Review the analytical reports.
2. Print Label as per requirement.
3. Filling the Rejection report for online rejection.
4. Preparing of Monthly Report on the basis of Raw / Packaging Material rejection report.
Head QA/Designee
1. Approval / Rejection of the material.
2. Verify storage of rejected material.
4.0 PROCEDURE:
4.1 Approval / Rejection procedure of Packing Material (PM):
4.1.1 Analyse the sample as per approved specification & record the observation in Record of Analysis.
4.1.2 The executed Record of Analysis along with other attachments shall be checked by QC personnel preferably section head.
4.1.3 After checking QC Personnel shall send the Record of Analysis along with raw data to QA Personnel for review and simultaneously enter the details in MATERIAL MANAGEMENT SOFTWARE.
4.1.4 QA Personnel shall review the report & stamp the report with green “Verified By QA” stamp (As per Annexure VI) and put the sign / date in the stamp with black pen only
4.1.5 After review the QA Head/Designee shall stamp with initial sign and date the report as “Approved” in green color or as “rejected” in red color as the case may be for approving or rejecting of material and Simultaneously Update the status in MATERIAL MANAGEMENT SOFTWARE.
4.1.6 The same Record of Analysis then shall be sent to QC head or the section head in QC for preparation of COA and printing the required labels.
4.1.7 After preparation of COA the same shall be transferred to QC Head for review and approval of COA and signing of goods inward memo (GIM).
4.1.8 Concern QC personnel shall enter the details in respective register.
4.1.9 Further the concern QC personnel shall print the label of approved (Green) or rejected (red) from MATERIAL MANAGEMENT SOFTWARE.
4.1.10 For Packing Material, number of labels shall be printed as per annexure VII. Check the details like Material Name, A. R. No. & G. I. M. No., with the “Under Test” label from the sampling sheet.
4.1.11 Paste one label of approved / rejected next to “UNDER TEST” label on sampling sheet.
4.1.12 Proceed to warehouse along with duly signed “APPROVED”/”REJECTED” labels and Paste on respective containers by covering “Under Test” label completely.
4.1.13 If material does not conform to the approved specification, prepare the rejection report as per annexure- I, and Paste “REJECTED” label on all packing material bundle / containers and send copy of rejection report to warehouse in charge, QA Head, Unit head.
4.1.14 Section head shall submit the report in QA with document hand over checklist.
4.2 Approval / Rejection procedure of Raw Material (RM):
4.2.1 Analyse the sample as per approved specification & record the observation in Record of Analysis.
4.2.2 The executed Record of Analysis along with other attachments shall be checked by QC personnel preferably section head.
4.2.3 After checking QC personnel shall send the Record of Analysis along with raw data to QA Personnel for review and simultaneously make the entry in MATERIAL MANAGEMENT SOFTWARE.
4.2.4 QA Personnel shall review the report & stamp the report with green “Verified By QA” stamp (as per annexure VI) and put the sign./ date in the stamp with black pen only.
4.2.5 After review the QA Head/Designee shall stamp with initial sign and date the report as “Approved” in green color or as “rejected” in red color as the case may be for approving or rejecting of material and Simultaneously Update the status in MATERIAL MANAGEMENT SOFTWARE.
4.2.6 The same Record of Analysis then will be sent to QC head or the section head in QC for preparation of COA and printing require labels
4.2.7 After preparing of COA the same shall be transferred to QC head for review and approval of COA and signing of goods inward memo (GIM).
4.2.8 Concern QC personnel shall enter respective details in respective register.
4.2.9 Further the concern QC personnel shall print the label of approved (Green) or rejected (red) from MATERIAL MANAGEMENT SOFTWARE.
4.2.10 Prepare n+1 “APPROVED” / n + 1 “REJECTED”/ status labels where “n” is the number of containers/Box received.
4.2.11 Paste one label of “APPROVED” / “REJECTED” next to “UNDER TEST” label on sampling sheet.
4.2.12 Proceed to warehouse along with duly signed “APPROVED / REJECTED” labels.
4.2.13 Paste “APPROVED”/ “REJECTED” label on all Raw material containers after checking details like material name, AR. NO. and GIM NO. with the “UNDER TEST” label from on the containers and paste the “APPROVED / REJECTED “ label by covering UNDER TEST label completely.
4.2.14 If material does not conform to the approved specification, prepare the rejection report as per annexure- I, and Paste “REJECTED” label on all raw material containers and send copy of rejection report to warehouse in charge, QA Head, Unit head.
4.2.15 Section head shall submit the report in QA with document hand over checklist.
4.3 On Line Rejection By QA Personnel at receipt bay area in warehouse.
4.3.1 In case the material is received in damaged /defective condition at the time of receipt, warehouse personnel shall generate the copy of defective material note as per current version of SOP on “Procedure for Receipt of Raw Materials/Packing material” and shall sent it to QA for Verification.
4.3.2 QA personnel shall verify the details and if decision is taken to reject the material the QA personnel shall raise rejection report as per annexure – II and simultaneously make entry in MATERIAL MANAGEMENT SOFTWARE and the report shall be sent to QA head / designee for review. The report shall be Approved/rejected by QA Head/designee and update the details in MATERIAL MANAGEMENT SOFTWARE.
4.3.3 QA personnel shall prepare the rejected label. A photocopy of the rejection report shall be sent to warehouse in charge for Handling and storage of rejected material.
4.3.4 QA Head/Designee will verify the storage of Rejected material.
4.4 On Line Rejection By QA Personnel at Production (Shop Floor).
4.4.1 Online rejection can be observed in following cases but not limited to:
4.4.1.1 In case of Raw Material:
4.4.1.1.1 Mix up error
4.4.1.1.2 Foreign matter
4.4.1.1.3 Wrong labeling Details
4.4.1.1.4 Physical damages of containers
4.4.1.1.5 Material status not observed suitable
4.4.1.1.6 Visual discrepancy
4.4.1.2 In case of Packing Material:
4.4.1.2.1 Mix up error
4.4.1.2.2 Foreign matter found in materials
4.4.1.2.3 Wrong labeling Details
4.4.1.2.4 Physical damages of containers
4.4.1.2.5 Visual discrepancy
4.4.2 In case of material rejected during online production activity at Shop Floor, material problem note is generated by Production as per current version of respective SOP on “Procedure for Extra Material Requisition and Material Problem note”.
4.4.3 After receipt of one copy of Material Problem note in QA, the QA personnel shall verify the details. If decision taken to reject the material by QA Head/Designee, QA personnel shall raise rejection report as per annexure – II and shall be approved by QA Head/Designee and QA personnel shall prepare the rejected label and update details in MATERIAL MANAGEMENT SOFTWARE.
4.4.4 A photocopy of the rejection report shall be send to warehouse in charge for Handling and storage of rejected material.
4.4.5 QA Head/Designee shall verify the storage of Rejected material.
4.5 Detail on Label
4.5.1 Detail on Label shall be as per MATERIAL MANAGEMENT SOFTWARE in case of Raw material and Packing material.
4.5.2 Details of “REJECTED” label During Online Rejection at Production for Raw/Packing Material.
4.5.6.1 A. R. No.
4.5.6.2 Name of Item
4.5.6.3 Product Name and B. No. for which issued for.
4.5.6.4 Rejected Qty.
4.5.6.5 Verified By QA Person
4.6 Reporting of Rejection for Raw / Packaging Material.
4.6.1 On basis of rejection report as per annexure I and II for raw material and packaging material rejection, prepare monthly report for material rejected as per Annexure V.
4.6.2 This monthly report shall be send to commercial department along with the copies to CQA and Unit Head.
4.6.3 Head QA shall identify the critical rejection from the monthly report.
4.6.4 Head QA shall fill the details in Annexure IV, based on the criticality identified and send it to CQA.
4.6.5 Commercial department shall arrange the CAPA from Vendor.
4.6.6 Head QA shall evaluate the Corrective and Preventive Action (CAPA) provided by the vendor.
4.6.7 Head QA shall enter the closure status after implementation of CAPA by vendor as per Annexure IV.
5. ANNEXURE (S):
Annexure – I Rejection Report (QC)
Annexure – II Rejection Report (QA)
Annexure – III Flow chart for Approval / Rejection of RM/PM
Annexure – IV Non conformance report
Annexure – V Monthly Report
Annexure – VI Specimen Stamps
Annexure – VII Number of label for packing material
Annexure I – Rejection Report (QC)
Date:
To,
Warehouse In charge,
Name of Item (Item Code):
Batch No.
Mfg. Date
G.I.M No/Date
Manufacturer
Qty. Received
Specification No:
A. R. No.
Exp. Date
Challan No./ Date
Supplier
Qty. Rejected
Rev.No.
Reason:
Analytical Findings:
Sr. No.
Test
Specification
Result
Prepared By:
Checked By:
Approved By:
Annexure II Rejection Report (QA)
Date:
To,
Warehouse In charge,
Name of Item (Item Code):
Batch No.
Mfg.Date
G.I.M No/Date
Manufacturer
Qty. Received
A. R. No.
Exp. Date
Challan No./ Date
Supplier
Qty. Rejected
Reason for Rejection:
Entry made in Related software:
Prepared By:
Checked By:
Approved By:
Annexure III: Flow Chart For APPROVAL / REJECTION of Raw Material / Packing Material
[Example not provided]
Annexure IV Non Conformance Report For CQA
Non conformance details:
Evidences/Enclosures:
Non conformance against
1. Product quality: ________________________________________________________
2.Productivity: ___________________________________________________________
3. Good manufacturing practice: _____________________________________________
4. Any Other (Specify): ____________________________________________________
Head QA (Location)
(Sign & Date)
Information received from vendor:
Corrective Action:
Preventive Action:
(Attach enclosures if any)
Disposition of the product finalized :
Head QA (Location)
(Sign & Date)
Closure
The implementation of CAPA is verified & found satisfactory. Hence the non conformance is closed.
Head QA (Location)
(Sign & Date
Annexure V: Monthly Report
Date:
Location:
Month & Year:
Rejection of Raw Material / Packaging Material
Sr. No
Material
Item code
Supplier
Challan No. & Date
A.R. No.
G.I.M No. & Date
Qty Recd
Qty Rejected
Date of Rejection
Reason for Rejection
Head QA (Location)
(Sign & Date)
Annexure VI Specimen Stamps
[Example not provided]
Annexure VII Number of labels for Packing Material
|
Material |
No. of label as per requirement |
|
|
Approved |
Rejected |
|
|
Primary packing material like PVC/PVDC/Aluminium foils |
(n X 2) + 1 |
(n X 2) + 1 |
|
In case of Bottle / Cap / Rayon etc |
n + 1 |
n + 1 |
|
For Secondary and miscellaneous other than shrink film |
n + 1 |
n + 1 |
|
shrink film |
(n X 2) + 1 |
(n X 2) + 1 |
|
tertiary packing material like corrugated Box |
n + 1 |
n + 1 |
Paste one set of approved / rejected label on Primary packing material like PVC/PVDC/Aluminium foils and shrink film on inner and outer side plus one on report [ label quantity (n X 2) + 1].
Other than above mentioned material paste label on each container outer side (Bundle / container) plus one on report [label quantity n + 1].
Here “n” is number of bundle / container