1.0 OBJECTIVE:
1.1 To lay down the procedure for sampling, release and rejection of Packaging material
2.0 SCOPE:
2.1 This procedure is applicable for sampling, release and rejection of Packaging material
3.0 RESPONSIBILITY:
3.1 Executive/Officer/Chemist : Quality Control Department
4.0 ACCOUNTABILITY:
4.1 Head-QC (or) his designee/deputy
5.0 REFERENCE(S):
5.1 In-House
6.0 ENVIRONMENT, HEALTH AND SAFETY
6.1 As per procedure
7.0 PROCEDURE:
7.1 Packaging Material:
7.1.1 Warehouse department makes Goods Receipt Note (GRN) & sends it to QC department for sampling and affix “QUARANTINE” label on each and every container.
7.1.2 After receiving the Goods Receipt Note (GRN) chemist/executive record into the “Incoming Packaging Material” log book as per Annexure -I and provides Analytical Report (A.R.) Number.
7.1.3 Check the details on the GRN for all the relevant details for sampling and note the observations on the sampling checklist for packaging material refer Annexure-II
7.1.4 Now refer Annexure-III to decide the number of container to be sampled from the total number of containers received.
7.1.5 Visually inspect the all samples and withdraw the quantity required for other tests as per specification. Confirm the acceptance quality limit refer Annexure -IV
7.1.6 Collect the withdrawn samples required for further analysis into self sealing polythene bag bearing label “sample for analysis”.And labeling on sampled container as per ANNEXUR-V
7.1.7 After sampling affix “UNDER TEST” label on each and every container which is been sampled as per ANNEXUR-VI
7.1.8 After the approval QC Chemist affixes the “APPROVED” labels over the “UNDER TEST” label on the container of consignment as per ANNEXUR-VII.
7.1.9 If Results are not within the approved specification of material shall be not released and affix
“REJECTED” label. the material to rejected As per Annexure –VIII.
8.0 HISTORY:
9.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
QCD : Quality Control Department
No. : Number
NA : Not Applicable
EQP : Equipment
AR : Analytical Report
GRN : Goods Receipt Note
10.0 ANNEXURE:
| Annexure No. | Title of Annexure |
| Annexure – I | Packaging material receiving record |
| Annexure –II | Checklist for Packaging Material |
| Annexure -III | Acceptance Quality Limit sample for Packaging Material
|
| Annexure -IV | Material Rejection Record |
| Annexure -V | Sampled Label |
| Annexure -VI | Under Test Label |
| Annexure -VII | Approved Label |
| Annexure -VIII | Material Rejection Label
|
ANNEXURE-I
Packaging material receiving record
| Sr. No. | Date | Name of Product | Mfg/Supplier Name | Received
Qty. |
A.R.No. | Done By | Checked By | Remarks |
ANNEXURE-II
Checklist for Sampling of Packaging Materials
| 1. | Manufactured/ Supplied By | Present / Not Present | Ok / Not Ok |
| 2. | Item code/ Item Description | Present / Not Present | Ok / Not Ok |
| 3. | Approved manufacturer/ supplier | Present / Not Present | Ok / Not Ok |
| 4. | Invoice No./Challan No. | Present / Not Present | Ok / Not Ok/ NA |
| 5. | Purchase Order No. | Present / Not Present | Ok / Not Ok/ NA |
| 6. | G.R.N Number | Present / Not Present | Ok / Not Ok/ NA |
| 7. | Date of Receipt | Present / Not Present | Ok / Not Ok |
| 8. | Batch No. | Present / Not Present | Ok / Not Ok |
| 9. | No. of Containers | Present / Not Present | Ok / Not Ok |
| 10. | Sign of Store Person | Present / Not Present | Ok / Not Ok |
(C) Details of Consignment:
| 1. | As per Standard Packing | As per GRN | Ok / Not Ok |
| 2. | Labelling on the Consignment | Should be proper | Ok / Not Ok |
| 3. | Physical Condition of the Consignment | Intact/Damaged | Ok / Not Ok |
| 4. | Product Name on the Consignment | Present /Not Present | Ok / Not Ok / NA |
| 5. | Batch No./ Challan No. | Present /Not Present | Ok / Not Ok |
| 6. | Name of the Manufacturer/ Supplier | Present /Not Present | Ok / Not Ok |
| 7. | Storage in proper allocated Area | Under Test Area | Ok / Not Ok |
Sampled By: Checked By:
Date: Date:
ANNEXURE-III
Acceptance Quality Limit sample for Packaging Material
| Total Number of
containers received |
Number of units to be sampled for analysis |
| Upto 50 | 8 |
| 50 – 90 | 10 |
| 91 – 150 | 13 |
| 151 – 280 | 17 |
| 281 – 500 | 23 |
| 501 – 1200 | 35 |
| 1201 – 3200 | 57 |
| 3201 – 10000 | 101 |
| 10000 to above | 174 |
ANNEXURE-IV
Material Rejection Record
| Sr.No | Name of Material | Manufactured
/Supplied By |
BatchNo.
/A.R.No |
Date |
Qty Rejected |
Rejected By | Reason for Rejection | Remarks | |
|
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ANNEXURE V
Sampled Label
|
SAMPLED |
|||
| Name of Packaging Material | |||
| Batch No. | Batch Size | ||
| Mfg. Date | Exp. Date | ||
| A.R. No. | Sampling Qty. | ||
| CONTAINER No. | Material code | ||
| Sampled By
(Sign & Date) |
Verified By
(Sign & Date) |
||
ANNEXURE VI
Under Test Label
|
UNDER TEST |
|||
| Name of Packaging Material | |||
| `Batch No. | Batch Size | ||
| Mfg. Date | Exp. Date | ||
| A.R. No. | Sampling Qty. | ||
| CONTAINER No. | Material code | ||
| Done By
(Sign & Date) |
Verified By
(Sign & Date) |
||
ANNEXURE VII
Approved Label
|
APPROVED |
|||
| Name of Packaging Material | |||
| `Batch No. | Batch Size | ||
| Mfg. Date | Exp. Date | ||
| A.R. No. | Sampling Qty. | ||
| CONTAINER No. | Material code | ||
| Approved By
(Sign & Date) |
Verified By
(Sign & Date) |
||
ANNEXURE VIII
Rejected Label
|
REJECTED |
|||
| Name of Packaging Material | |||
| `Batch No. | Batch Size | ||
| Mfg. Date | Exp. Date | ||
| A.R. No. | Sampling Qty. | ||
| CONTAINER No. | Material code | ||
| Rejected By
(Sign & Date) |
Verified By
(Sign & Date) |
||