SOP for receipt and storage of Raw and packing material.
This Document describes (Standard Operating procedure) SOP for receipt and storage of Raw and packing material.
SOP for receipt and storage of Raw and packing material.
I. Purpose & Scope:
- The purpose of this SOP for Receipt and storage of Raw and packing material.
- This Standard operating procedure shall be applicable for receipt and storage of Raw and packing material.
II. Responsibilities:
- All warehouse personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part:
PROCEDURE:
- Whenever a Raw and packing material (raw/packing/solvent) is received at factory gate the security personnel shall approach to the driver of vehicle/ transporter representative and collect the documents (supplier’s challan/Invoice/driver’s packaging slip or Bill of Lading) for the material loaded in the vehicle.
- Security personnel shall verified the documents for company name and availability of related all documents, after verification security personnel shall bring the documents and handover to warehouse person for further verification.
- Warehouse personnel shall check the correctness of material, documents & whatever requirement as per Company policy. If the all documents are found satisfactory then warehouse person shall give clearance to security person for allowing the material inside the factory premises.
- As per clearance by the warehouse person, the security department shall enter Security Inward register and security shall stamp (violet ink) on the back side of the challan/Invoice.
Receipt of Documents & Vehicle Check.
- Before unloading the material, vehicle shall be checked for following:-
- Absence of any sensitizing material (such as Beta lactum, hormones, cytotoxic) which can contaminate to the other materials/ People.
- Materials are properly segregated.
- Any obnoxious smell in the vehicle.
- Spillage of any material in the vehicle.
Check the transportation documents as follows but not limited to this –
- Lorry receipt copy.
- Delivery Challan/Invoice.
- E- Way bill.
- Purchase order details.
- Item code availability.
- Approved vendor source.
- Manufacture COA (Certificate of Analysis).
- Pharmacopoeia references.
- Above Checks shall be recorded on Material Receiving Checklist if any discrepancy observed immediately informed to Head Warehouse and Quality Assurance.
- If any of the above is observed during vehicle inspection same shall be reported to Head warehouse and Head QA. Material shall be unloaded after clearance for unloading the material from Head warehouse and Head QA.
- If vehicle/material condition is not OK, vehicle/material shall be sent back and put remark in receiving checklist, Same shall be inform to Head warehouse and QA departments.
UNLOADING OF Raw and packing material :
- Before opening the receiving bay shutter ensure that Insecticutor is on and Air curtain is working.
Unload the Raw and packing material at Receiving bay as follows:
- For Raw and packing Materials & Solvent Unload each material as per batch number wise/lot wise on separate pallet. Do not unload two different materials at a time.
- It shall be ensured that Foil/PVC roll is in well closed condition with proper shrink wrapping, if wrapping is not proper then It should be shrink wrapped after material unloading. Note – All Packs shall be mopped with 70%
- During unloading if any discrepancy observed, fill up the deficiency note of consignment mention the same on L.R Copy / challan copy. Inform the PPIC/Purchase depart to communicate with the supplier.
- If any discrepancies observed in above checks same shall be reported to head warehouse & head QA.
- If any discrepancies observed which can’t be sorted out immediately, the Raw and packing material shall be kept under hold.
- Affix “Under Hold” label and place the container in “Quarantine Area” till further decision.
- The decision of Raw and packing material under hold shall be taken within 15 working days.
- Put the Stamp as “Goods Received” (violet ink) on front side of delivery challan/Invoice and hand over to transporter.
- On verifying the acknowledged documents the security personnel shall allow the vehicle to go out of the gate.
- Stack the material on pallet and transfer it to de dusting area and close the shutter.
- Transfer the materials in weighing area for verification of gross weight/Nos.
De-Dusting and physical verification of Raw and Packing material :
- Outer surface of the container shall be cleaned with the vacuum cleaner followed by dry lint free cloth.
- Physical verification of material shall be performed and recorded as per material receiving checklist .
- Containers physical condition: containers shall be verified for any damage and/or spillage of material from its Intactness of container such as seal integrity and sealing tape integrity shall be verified for any evidence of tempering.
- Containers label: Labeling details on container shall be verified for
- Raw and packing material name/Description as per item code list and approved vendor list.
- Manufacturing date.
- Batch no. /lot no.
- Best before usage date/Expiry date/Retest date/ Revalidation date.
- Pharmacopoeia reference.
- Manufacturer and suppliers address as per approved vendor list.
WEIGHING PROCEDURE
- Ensure that balance is verified as per SOP on Operation, calibration and cleaning of digital electronic weighing balance.
- Check all weight or count physically and document discrepancies if any.
- Permitted variance for Raw and Primary packing material:
Standard Pack (Gross Weight) | Percentage Limit |
Up To 05 Kg. | ± 2.0 % |
05 To 25 Kg. | ± 1.0 % |
25 To 50 kg. | ± 0.5 % |
50 To 100 kg. | ± 0.3 % |
More than 100 Kg. | ± 0.2 % |
The Raw and packing material shall be verified for the quantity received as follows.
- For Raw material container /Bag: Warehouse personnel shall take gross weight of each and every container/bag/Boxes & shall note gross weight in the ‘Material Weighing Record’ . If gross weight is less/excess than the labeled gross weight on the container remark shall be mentioned on the ‘Material Weighing Record’ and the difference obtained shall be recorded. The difference shall be within specified limit as mentioned above.
- For Foils and PVC / PVDC: Each roll shall be weighed and recorded in the ‘Material Weighing Record’ . If weight of the Roll is less/excess than the labeled weight remark shall be mentioned on the ‘Material Weighing Record’ and the difference obtained shall be recorded. The difference shall be within specified limit.
- Printed Packing Material shall be verified for numbers of boxes or bundles if these are required to be opened for verification, it shall be transferred to packing material sampling area and quantity shall be verified.
- Solvent Barrels: Each barrel shall be weighed and recorded in the ‘Material Weighing Record’ . Record the difference, the difference shall be within specified limit.
- For other packing materials like Corrugated Boxes shall be checked randomly to verify the consignment received.
- Warehouse personnel shall inform Head Warehouse and QA Head for any discrepancy observed. Quality Assurance shall inform purchase regarding the variation observed to get same with supplier for taking correction in future consignment.
- Existing label (manufacturer’s approved label/transporter label) on container shall be marked with cross mark “X” by using marker pen.
- Goods Receipt Note (GRN) shall be prepared by warehouse for actual receipt Quantity as observed during physical verification of Raw and packing material allocates a” GRN number” , accordingly “Quarantine label” shall be generated through software.
GRN numbering shall be done as follows :
GRN Number: XXXX/YYYY /ZZZ/NNNN
Where alphabets denotes as follows:
- XXXX: Company short form
- YYYY: Stands for last two digit of Current Financial Year (eg. 20 for 2020)
- ZZZ: Stands for RM-Raw Material / PM- Packing Material
- NNNN: Sequential Serial Number (e.g. 0001, 0002……) (it starts from 0001 from every financial year i.e. from 1st April onwards).
- While preparing GRN precaution shall be taken to avoid any typographical error or transcription error.
- After preparation of GRN, Quarantine label shall affix to each and every container /Bags /Cartons. While affixing the Quarantine label warehouse officer shall ensure that vendor/Supplier information of container/bag should not be hide.
Labelling pattern of Quarantine Label :
- On each container on the left side position of the manufacturer’s label.
- In case of bags, affix the label on a plain card and tag it to the bottom of bag.
- In case of foils and PVC rolls, affix the labels on the inner surface of the core.
- In case of shipper bundles, affix minimum two labels on the consignment kept on each pallet.
- For Solvent / Liquid raw material each barrel/container at the side top position.
- Supplier label from the damaged container shall be removed and affixed on the new container. If Supplier label is not removable from the container, its picture shall be taken and affixed on new container and the quarantine label shall be affixed.
- Replacement of the container/label shall be recorded in “Material Receiving Checklist.
Raw and packing material movement :
- Warehouse Personnel shall transfer the Raw and packing material from weighing area to their respective area.
- Incase specific storage condition is required, received Raw and packing material shall be transfer immediately to respective storage area/condition.
- Container of EHG shells/Hygroscopic materials shall be kept in controlled temp. & RH store.
- Forward Goods Receipt Note (GRN) along with Certificate of Analysis to Quality control to carry out sampling.
- Raw and packing material sampling shall be performed as per respective SOP.
- Quality personnel shall affix “Under Test” label to the front of upper part of the quarantine label that hide “Quarantine” name and shift the Raw and packing material to “Under Test” area.
- Once the Raw and packing material is Approved or Rejected by Quality control, the Quality control department shall send the Goods Receipt Note (GRN) to warehouse with all the details i.e. Analysis Report Number (A.R. No) with Release or Rejected Date, and Certificate of Analysis.
- After QC release, QC personnel shall be affixed “Approved” label in place of under test label of each and every container. The QC personnel shall ensure that under test label shall be hide from approved label.
- If any Raw and packing material is rejected, QC person shall affix the “REJECTED” label as per after that the rejected material shall transferred “Rejected area” which shall be kept under lock & key condition and updated rejected material record . The key shall be kept under the custody of head QA or to his authorized nominee.
- Warehouse person shall transfer the approved material to the approved storage area and accordingly updated the location as per the location chart .
- Container label shall be verified for any specific storage condition and Raw and packing material shall be kept in a way to meet the required storage condition.
- Storage condition list shall be prepared by officer/executive warehouse, checked by Head warehouse and approved by Head QA. Storage condition list updated.
- Storage Condition list shall be numbered as SCL/XX/RR
Where as,
- SCL: Storage Condition list.
- XX: Stands as RM for raw material and PM for packing material.
- RR: Stands for revision no. of list such as 00, 01, 02, 03, 04…… and so on.
- Addendum to storage condition list shall be prepared in case of addition of any new Raw and packing material or change in storage condition.
- Addendum to storage condition list shall be numbered as sequentially as 01 of 05, 02 of 05, 03 of 05 and so on.
- On issuance of 05 addendum (05 of 05) to storage condition list, the storage condition list shall be revised and all addendum shall be included in the list.
- Warehouse officer / Executive shall ensure the following warning during receipt and storage and shall store the Raw and packing material at their specific place.
ANNEXURE:
Annexure I | Deficiency note of Consignment. |
Annexure II | Material Receiving Checklist. |
Annexure III | Goods receipt note. |
Annexure IV | Location chart. |
Annexure V | Material storage condition List. |
Annexure VI | Material weighing record. |
Annexure-I
DEFICIENCY NOTE OF CONSIGNMENT
From: Stores | To: Quality Assurance | ||||
The Following deficiencies are observed in the consignment during receipt: | |||||
1. __________________________________________________________________________ 2. __________________________________________________________________________ 3. __________________________________________________________________________ |
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Consignment details: | |||||
Item Code | Item Name | P.O. No. | Supplier | Challan No. / Date | Qty. |
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Prepared By : ___________________ (Warehouse In Charge) |
Date: | ||||
Q.A. Inspection & further instruction:
Verified By : (Sign/Date ) |
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CC: Purchase Dept. |
Annexure-II
MATERIAL RECEIVING CHECKLIST
General Check
Material belongs to Customer | Yes / No | ||
Ref Gate Entry No. | Date | ||
Name of Material | |||
Item Code | Mfg. Date | ||
B. No. | Exp. Date | ||
Name of Supplier & address | |||
Is Supplier available in approved vendor list | Yes / No (if ‘No’ then inform to QA ) | ||
Name of Manufacturer & address | |||
Is Vendor Approved & available in approved vendor list | Yes / No (if ‘No’ then inform to QA ) |
Documents | Availability | ||
Yes √ | No r | NA | |
Certificate Of Analysis | |||
Lorry Receipt Copy | |||
Delivery Challan | |||
Invoice/Duplicate for transporter copy | |||
E way Bill | |||
Quantity verified as per challan qty. | |||
P.O. No. and Date |
Document Check
Physical Verification
Details of verification of vehicle before unloading of material | a | Proper closed condition of vehicle | OK / NOT OK | ||||||
b | Physical segregation of Material | OK / NOT OK | |||||||
c | Absence of sensitizing material | OK / NOT OK | |||||||
d | Cleanliness of vehicle | OK / NOT OK | |||||||
Packing condition | Satisfactory / Not satisfactory | ||||||||
Condition of seals and packs | Satisfactory / Not satisfactory | ||||||||
Container label details verification | Yes / No | ||||||||
Material storage condition during Transportation (Refer Container/Non Refer Container) | Yes / No | ||||||||
Pharmacopoeia references as per P.O. and approved vendor list | |||||||||
Quantity Received | |||||||||
Total No. of Containers/bags/box & Quantity in each pack | |||||||||
Remarks ( if any): | |||||||||
Prepared By :
Sign/Date (WH) |
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Checked By : Sign/Date (WH) |
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If any discrepancy : Comments
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HOD (WH) Sign/date | HOD (QA) Sign/date | ||||||||
ANNEXURE-III
GOODS RECEIPT NOTE
On A/C of: _________
Supplier : GSTIN :
Transporter: Vehicle No: L.R No. : Date : |
Type
GRN No. PO/Ref No.
Invoice No. Challan No.
Inward No. |
: : :
: :
:
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Date
Date
Date Date
Date |
: :
: :
:
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Material
Code HSN/SAC Code |
Description
Manufacturer
|
Batch No.
UOM
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Mfg.Dt
Exp.Dt. Reval.Dt
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Approved Date
AR No.
|
Tot. Packs
Qty./Pack
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Challan Qty.
Rec.Qty. Rej. Qty.
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Acc. Qty.
Smp.Qty
|
Rate
Amount |
Tax (%) Amount | ||
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Sub –total :
Total Amount: GST |
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Net Amount Rs. :
Prepared By: Approved/Rejected By Authorized By Stores QC |
ANNEXURE-IV
FORMAT FOR LOCATION CHART
Warehouse | ||
Title: Location Chart | Page 1 of 1 |
Sr. No. | Item Code | A.R. Number | Location | Location Updated by (Sign & Date) | Location Removed by (Sign & Date) |
Annexure-V
Material Storage Condition List
SCL No. | Rev. No. | Addendum No. | Effective Date |
|
Item Code | Name of Material | Spec. | Storage Condition |
Warehouse | Department Head | QA Head |
Prepared By/ Sign / Date | Checked By/ Sign / Date | Approved By/ Sign / Date |
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Annexure-VI
Material Weighing Record
Ref Gate Entry No. | Date | ||
Name of Material | Item Code |
Container No. | Lot No / Batch No | Gross wt. /Nos. (on label claim ) | Physical Gross wt. /Nos. | Difference (If any)
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Remarks |
Weighted By /Date Verified By/Date
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Difference if any ( Comments)
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HOD (WH) Sign /date | HOD (QA) Sign/date |