Raw materials presentation

Raw materials presentation

• 1.
  SAMPLING, TESTING AND RELEASE/ REJECTION OF RAW MATERIALS Presented by Malangsha [email protected] 1 SAMPLING, TESTING AND RELEASE / REJECTION OF RAW MATERIALS Presented by Malangsha [email protected]
• 2.
  Quality control shallreceive "Material Received Report (MRR) from Warehouse as an intimation for raw material sampling. Upon receipt, sampling Executive shall verify the details on the MRR and supplier COA. Sampling Executive shall enter the details in the Raw Material Inward Record as per the MRR and assigns an Analytical Reference Number as per SOP. Sampling I analysis priority shall be decided upon the requirement of material and production plan, in case of multi MRR receipt. Executive-QC shall prepare the required number of labels (i.e., "Sample for analysis" and"Sampled") as defined in the below sampling plan. 2 Quality control shall receive "Material Received Report (MRR) from Warehouse as an intimation for raw material sampling. Upon receipt, sampling Executive shall verify the details on the MRR and supplier COA. Sampling Executive shall enter the details in the Raw Material Inward Record as per the MRR and assigns an Analytical Reference Number as per SOP. Sampling I analysis priority shall be decided upon the requirement of material and production plan, in case of multi MRR receipt. Executive-QC shall prepare the required number of labels (i.e., "Sample for analysis" and"Sampled") as defined in the below sampling plan.
• 3.
  Sampling plan 1 to5 All 6 to 10 6 11 to 20 7 21 to 56 8 More than 56 --./n+ 1* If the decimal in --./n value is less than 5, it shall be rounded to the lowest value, if it is more than or equal to 5, it shall be rounded to the highest value. 3 Sampling plan 1 to 5 All 6 to 10 6 11 to 20 7 21 to 56 8 More than 56 --./n+ 1* If the decimal in --./n value is less than 5, it shall be rounded to the lowest value, if it is more than or equal to 5, it shall be rounded to the highest value.
• 4.
  Note: For thenew vendor first three consignments of starting raw materials, composite sample shall be prepared from all the containers (100% sampling), irrespective of the sampling plan. Executive-QC shall carry self-sealed polyethylene bags, glass bottles, cleaned sampling devices (such as SS Scoop, thief sampler/glass sampler), prepared labels and sampling record to proceed for sampling.  Sampling Executive shall verify the physical condition, consignment details and "Under Test" label of the containers against MRR. In case of discrepancy the same shall be recorded and immediately informed to warehouse in charge for rectification. 4 Note: For the new vendor first three consignments of starting raw materials, composite sample shall be prepared from all the containers (100% sampling), irrespective of the sampling plan. Executive-QC shall carry self-sealed polyethylene bags, glass bottles, cleaned sampling devices (such as SS Scoop, thief sampler/glass sampler), prepared labels and sampling record to proceed for sampling.  Sampling Executive shall verify the physical condition, consignment details and "Under Test" label of the containers against MRR. In case of discrepancy the same shall be recorded and immediately informed to warehouse in charge for rectification.
• 5.
  Executive-QC shall randomlyselect the containers for sampling and instruct the warehouse personnel to shift the same containers to sampling booth. Executive-QC shall wear the safety devices and proceeds for sampling of selected containers one by one in the sampling booth. Sampling Executive shall check the physical appearance of the material and mix the contents thoroughly within the container by sampling devices (SS scoops/Thief sampler for solids or glass sampler for liquids) and collects the sample in self sealed bags (for solids) and glass bottles (for liquids). 5 Executive-QC shall randomly select the containers for sampling and instruct the warehouse personnel to shift the same containers to sampling booth. Executive-QC shall wear the safety devices and proceeds for sampling of selected containers one by one in the sampling booth. Sampling Executive shall check the physical appearance of the material and mix the contents thoroughly within the container by sampling devices (SS scoops/Thief sampler for solids or glass sampler for liquids) and collects the sample in self sealed bags (for solids) and glass bottles (for liquids).
• 6.
  Post sampling, containershall be sealed or closed immediately and "Sampled" labels shall be affix on the containers adjacent to under test Labels.  Sampling Executive shall take equal quantity from each container and collect composite sample .  If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC.  In such case Head-QC along with QA representative shall approach ware house and verifies the physical appearance of the material. 6 Post sampling, container shall be sealed or closed immediately and "Sampled" labels shall be affix on the containers adjacent to under test Labels.  Sampling Executive shall take equal quantity from each container and collect composite sample .  If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC.  In such case Head-QC along with QA representative shall approach ware house and verifies the physical appearance of the material.
• 7.
  If the materialis confirmed failing in physical appearance, consignment shall be rejected without OOS investigation. If the physical appearance of the material in all the containers is similar and complying, all the samples shall be collected compositely.  All observations of sampling shall be recorded in "Raw material sampling record" Sampled containers shall be shifted to their original place immediately. Details of sampling shall be entered into the sampling booth usage and cleaning record of warehouse. 7 If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation. If the physical appearance of the material in all the containers is similar and complying, all the samples shall be collected compositely.  All observations of sampling shall be recorded in "Raw material sampling record" Sampled containers shall be shifted to their original place immediately. Details of sampling shall be entered into the sampling booth usage and cleaning record of warehouse.
• 8.
  Collected composite sampleshall be brought to QC and divided into 3 parts in sample distribution area. One part shall be preserved as retention sample (for starting raw material only) and other two parts shall be used for complete analysis (at wet and Instrumentation labs) The QC Analyst shall test the samples as per respective standard test procedures.  If the sample meets the individual specification, material shall be approved and retention sample shall be logged. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. 25.0 Based on the investigation status of the material shall be 8 Collected composite sample shall be brought to QC and divided into 3 parts in sample distribution area. One part shall be preserved as retention sample (for starting raw material only) and other two parts shall be used for complete analysis (at wet and Instrumentation labs) The QC Analyst shall test the samples as per respective standard test procedures.  If the sample meets the individual specification, material shall be approved and retention sample shall be logged. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. 25.0 Based on the investigation status of the material shall be
• 9.
  Liquid raw materials(in tankers) sampling sequence: Sampling Executive shall take prepared sample labels, Glass bottles, sampling checklist, Glass sampler and proceeds for sampling. Sampling Executive shall verify the compartment wise Seal Naive intact and "Under test labels" before sampling.  Sampling Executive shall break the compartment seals and open the lids one by one. Sampling Executive shall rinse the sampler thrice with the material and collect the samples from the top of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments. 9 Liquid raw materials (in tankers) sampling sequence: Sampling Executive shall take prepared sample labels, Glass bottles, sampling checklist, Glass sampler and proceeds for sampling. Sampling Executive shall verify the compartment wise Seal Naive intact and "Under test labels" before sampling.  Sampling Executive shall break the compartment seals and open the lids one by one. Sampling Executive shall rinse the sampler thrice with the material and collect the samples from the top of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments.
• 10.
  Sampling Executive shallopen the bottom valves and drain about 5 to 10 liters of the liquid into buckets. Then samples shall be collected from bottom of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments. Post sampling, compartments shall be sealed or closed immediately and "Sampled" labels shall be affix on the tanker adjacent to under test Label. If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC. 10 Sampling Executive shall open the bottom valves and drain about 5 to 10 liters of the liquid into buckets. Then samples shall be collected from bottom of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments. Post sampling, compartments shall be sealed or closed immediately and "Sampled" labels shall be affix on the tanker adjacent to under test Label. If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC.
• 11.
  ln such caseHead-QC along with QA representative shall personally verify the physical appearance of the material. If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation.  If the physical appearance of the material in top / bottom portion is similar and complying, a composite sample shall be prepared and brought to QC for analysis. The QC Analyst shall test the samples as per respective standard test procedures. If the sample meets the individual specification, material shall be approved and tanker material shall be unloaded into bulk storage tank. 11 ln such case Head-QC along with QA representative shall personally verify the physical appearance of the material. If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation.  If the physical appearance of the material in top / bottom portion is similar and complying, a composite sample shall be prepared and brought to QC for analysis. The QC Analyst shall test the samples as per respective standard test procedures. If the sample meets the individual specification, material shall be approved and tanker material shall be unloaded into bulk storage tank.
• 12.
  Quantity unloaded shallbe intimated by warehouse and the same shall be recorded in the raw material inward! sampling check list and protocol. Warehouse shall request a fresh A.R.No. for the composite material of storage tank once unloading is completed. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. Based on the investigation, status of the material shall be decided accordingly. Analyst shall perform the analysis as per the product STP and records the raw data in the. "Raw material test protocol". 12 Quantity unloaded shall be intimated by warehouse and the same shall be recorded in the raw material inward! sampling check list and protocol. Warehouse shall request a fresh A.R.No. for the composite material of storage tank once unloading is completed. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. Based on the investigation, status of the material shall be decided accordingly. Analyst shall perform the analysis as per the product STP and records the raw data in the. "Raw material test protocol".
• 13.
   Analyst shallrecord instrument usage details in respective equipment logbooks. Analyst shall attach the calculations / observations / chromatograms with the test protocols. Test wise results shall be compiled in the certificate of analysis and forwarded to reviewer (section head) for cross verification. Section head shall review the raw data thoroughly and upon execution further forwards the report to Head-QC/Deputy for approval. In-charge - QC I deputy shall verify the data randomly and approves the document for release. 13  Analyst shall record instrument usage details in respective equipment logbooks. Analyst shall attach the calculations / observations / chromatograms with the test protocols. Test wise results shall be compiled in the certificate of analysis and forwarded to reviewer (section head) for cross verification. Section head shall review the raw data thoroughly and upon execution further forwards the report to Head-QC/Deputy for approval. In-charge - QC I deputy shall verify the data randomly and approves the document for release.
• 14.
   Status label(Approved/Rejected labels) labels shall be prepared and pasted on the under test labels of the containers. MRR shall be sent to warehouse with status details along with certificate of analysis.  In the case of failure in quality parameters, OOS (Out of specification) shall be initiated for raw materials.  Further thorough investigation shall be carried out with document evidence for OOS materials.  Based on the investigation recommendation, status of the material shall be concluded. The final status of the material shall be recorded in the raw material inward registers along with date of release. 14  Status label (Approved/Rejected labels) labels shall be prepared and pasted on the under test labels of the containers. MRR shall be sent to warehouse with status details along with certificate of analysis.  In the case of failure in quality parameters, OOS (Out of specification) shall be initiated for raw materials.  Further thorough investigation shall be carried out with document evidence for OOS materials.  Based on the investigation recommendation, status of the material shall be concluded. The final status of the material shall be recorded in the raw material inward registers along with date of release.
• 15.
  Gases, Hazardous andToxic raw materials:  Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw materials sampling Executive shall verify the details on the MRR and supplier/manufacturer COA.  Sampling Executive shall enter the details in the Raw Material Inward register as per the MRR and assigns an Analytical Reference Number. Sampling Executive shall approach the consignments and visual verification shall be done. 15 Gases, Hazardous and Toxic raw materials:  Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw materials sampling Executive shall verify the details on the MRR and supplier/manufacturer COA.  Sampling Executive shall enter the details in the Raw Material Inward register as per the MRR and assigns an Analytical Reference Number. Sampling Executive shall approach the consignments and visual verification shall be done.
• 16.
  Sampling shall notbe performed for such raw materials and released as per the vendor certificate of analysis. In the case of captive consumption material transfers, earlier tested certificate of analysis shall be considered for release. 16