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SOP for Sampling of Raw Material

OBJECTIVE 
To lay down a procedure for Sampling Raw Material for analysis. 

SCOPE 
This SOP shall be applicable for the Sampling of all Raw Materials received at Rene Industries Limited. 

RESPONSIBILITY 
The Chemist - Quality Control (QC) shall be: 
  • Responsible for receiving the intimation from store and entering the details in RM register. 
  • Responsible for the ensuring appropriate cleanliness of the sampling room, and sampling devices before sampling. 
  • Responsible for ensuring proper documentation for sampling and assembling of an adequate number of items for sampling. 
  • Responsible for proper sampling of RM from the container and its appropriate identification on each sampled container. 
  • Proper labeling of containers. 


PROCEDURE 
  • QC chemist shall receive intimation slip from RM store & shall do entry in raw material register.


PREPARATION OF SAMPLING
  1. Check and verify the sampling room with regards to cleaning. 
  2. If any of the location is not clean get it cleaned before sampling. 
  3. Balance calibration and verification record 

Shifting of the RM containers from quarantine area to sampling area 
  1. Take the intimation slips and sampling remark format and go to Warehouse – Raw Material Quarantine area. 
  2. Check and Verify the details of container(s) as per Annexure-1 
  3. Bring the RM container(s) nearer to the sampling room on clean pallet. 
  4. Clean the container from outside before taking in sampling room. 
  5. Take the material container (s) inside the sampling room one after another and number each container as Container No.­­ of N­­­­­­ where N is the total number of the containers received in the batch / lot. 
  6. Open the containers only one after other. 
  7. During sampling do not keep two different material container(s) as well as different batch of same materials at a time to avoid any mix-up. 
  8. Use sampling device of appropriate size for one material only. In case of sampling more than one batches of same material, use different sampling devices. 
  9. Take special precaution while sampling liquid materials like solvents. Use special S.S. device/Glass tubing only for liquid. 


SAMPLING OF RAW MATERIAL 
  • Proceed to the stores along with sampling checklist, sampling devices, labels etc. 
  • Label the sample bag or container properly & keep it ready. Arrange the raw material containers which are to be sampled in sampling booth area.
  • Observe visually for appearance of the material for any abnormalities like discoloration, lumps, non-characteristic odour, foreign matter, physical heterogeneity etc. 
  • In case of any abnormalities observed, inform to Head – QA / QC for final disposition. 
  • The concerned Sampling person should do sampling as per sampling plan table for different type of materials given below. 


  • If batch size or qty of consignment is more than 500 kg then sample quantity should be 2 times as given in Annexure-2. 
  • Maximum no. Of container for one pooled sample shall be 20 and for every 20 containers, there be one pool sample. Likewise one sample is pooled for every additional 20 containers. After withdrawal of quantity for assay, prepare composite sample by mixing remaining quantity. From this composite sample, prepare sample for complete analysis & sample for Control sample. 


  • Withdraw approximately equal quantities from all containers / packs for preparing pooled sample (Composite Sample) using following clean sampling equipments.


  • Label the container in which samples are taken with appropriate pooled Sample (Sample for Analysis) label 
  • Affix “UNDER TEST’’ label on each container and label of “SAMPLED” to container from which sample withdrawn and close the container properly with cable tie. 
  • Close the sampled container tightly; label shall be affixed on sampled bottles. 
  • Send samples along with inspection sheet and Manufacturer's Certificate of Analysis to Quality Control Laboratory for analysis. 

ABBREVIATION
SOP : Standard Operating Procedure 
No. : Number 
QC : Quality Control 
QA : Quality assurance 
RM : Raw Material 
No : Number


ANNEXURE
Annexure -1 -- Raw material sampling checklist/record 
Annexure -2 -- Sample Quantity list
 

REVISION HISTORY
Nil

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