Sampling, Testing and Approval/Rejection of Packaging Material – SOP


SOP for Packaging Material Testing | Sampling plan for packaging materials | AQL for packaging material |

  • SOP for Packaging Material covers below points :
    • Receiving procedure of Goods Receipt Note (GRN)
    • Sampling plan for packaging materials / Planning for Sampling of Packaging Materials
    • AQL for packaging material / Acceptable Quality Level (AQL) inspection
    • Testing of Packaging Materials
    • Approval procedure of Packaging Material
    • Rejection procedure of Packaging Material
    • Sampling Plan as per Acceptance Quality Level (AQL) for Packaging Materials format
    • Acceptance Quality Level (AQL) of Packaging Material format
    • Acceptance Quality Level Observation of Packaging Material format
  • To provide procedure for sampling, testing and approval/ rejection of packaging material based on statistical sampling Plan.
2.0 SCOPE :
  • This procedure is applicable to sampling of all primary, secondary and tertiary packaging material and testing and approval/ rejection of packaging materials with respect to the laid down standards.
  • Quality Control Chemist and above
  • Quality Control Head
5.1 Definitions
  • Batch Number (or Lot Number):  A distinctive combination of numbers and/or letters, which specifically identify a batch or lot and permit its history to be traced.
  • GRN No.: A distinctive sequential number allotted by packaging material warehouse for receipt of each consignment of a material batch wise and receipt wise.
  • Sampling: The process of abstraction of a portion of material from a larger quantity.
  • Primary packaging material: The packaging material which  is in direct  contact with product. e.g. Aluminium foils,  PVC and PVdC coated PVC film, HDPE container, Glass bottle,  Poly-laminated paper etc.
  • Secondary Packaging material: The Packaging material which is not in direct contact with product. e.g. Cartons (inner/ Outer), leaflet,  Catch cover etc.
  • Tertiary Packaging material: The Packaging material which is not in direct contact with product, used to protect manufactured goods. e.g. Shrink, Corrugated box, BOPP tape,  Strapping roll etc.
5.2 Receiving of Goods Receipt Note (GRN):
  • Warehouse department receives the packaging material & checks for the condition of shipment and actual quantity of packaging material received as per purchase order.
  • Warehouse department creates Goods Receipt Note (GRN) in ERP system and sends to Quality Control Department along with manufacturer’s COA, wherever applicable. In case COA is not received, inform to Head.
  • After receiving GRN, verify that the vendor is qualified against approved vendor list. If not, refer the matter to Head.
  • Enter the details of materials such as Date, GRN No., Name of material, Quantity received, Quantity sampled, Name of supplier in Packaging Materials Register.
  • Assign Analytical Report number (AR No.) as per SOP of Assigning Analytical Report Number, and mention AR No. in Packaging Materials Register.
5.3 Planning for Sampling of Packaging Materials:
  • Sampling Personnel
    • Personnel, who have been appropriately trained for the sampling purpose, shall carry out sampling.
    • Personnel should be observant, meticulous and should understand the nature of material being handled.
  • Pre-checks before sampling and precaution
    • Before sampling, ensure that the packages in which materials are received are properly packed.
    • Before sampling, identify that sample containers are properly labeled for the name of the material and other details of the consignment.
    • Verify the exterior of the container, clean it if required.
    • Check for number of containers received against the GRN.
    • Check and compare the details of packaging material on manufacturer’s COA, GRN and label affixed on the containers.
    • In case outer box is damaged, check the inner box and if it is in good condition, perform sampling.
    • If the sampling is performed from outer damaged container, instruct to ware house person to replace the material with in-house satisfactory container and pack the container in a proper way to avoid the further damage to the material.
    • In case outer as well as inner box is damaged, affix “ON HOLD” label and bring it to the notice of QC Head and QA Head with complete documentation of incident.
    • The sampling of primary packaging materials such as Aluminium foils,  PVC and PVdC coated PVC film, HDPE container, Glass bottle,  Poly-laminated paper will be carried out in sampling booth under reverse laminar air flow (RLAF).
  • Sampling
    • Carry out sampling for each GRN.
    • Check the general conditions of the containers/ boxes/ pack in the consignment.
    • Confirm the details like Name of material, Batch No./ Lot No.(if applicable), Name of supplier and GRN No. These should be matched with GRN.
    • Ensure that “QUARANTINE” Label is affixed by Warehouse department.  For all packaging  materials, minimum 25% of the total number of packs shall have “QUARANTINE” label.
    • Clean the exterior of the container.
    • Sampling of Packaging material should be performed within a week after creation of GRN.
    • Collect the samples randomly from (n+1) packs/containers where ‘n’ stands for total number of packs received.
    • Total 10 meters of printed foils shall be collected from all selected rolls after discarding first 0.5 meter foils from the each roll.
    • Sampling and inspection for Acceptance Quality Level (AQL) Inspection shall be performed as per point No. 5.4.
    • Collect the samples (except corrugated box) in a clean dry polythene bags and label them properly.
    • After sampling, affix the label “SAMPLED” with signature and date of sampling on those containers from which the sample are taken.
    • Enter the following details and affix a yellow coloured “UNDER TEST” label on the  consignment with at least the following details;
      • Material name     
      • Quantity received
      • G.R.N. number with Date
      • Manufacturer’s Name                                                     
      • Supplier’s Name, if different
      • Name of the person who sampled along with date
    • After sampling is over, ensure that the containers / packets / boxes are properly closed.
    • In case of any variance in supply due to unavoidable circumstances, purchase department should inform to Q.C. Head or his/her designee in advance or with supply. However, opinion of Q.C. Head will be final for acceptance or rejection of it.
    • 5.4 Acceptable Quality Level (AQL) inspection:
    • Sample size for Acceptable Quality Level (AQL) inspection, which is statistical methodology for quality inspection purpose, shall be decided as per the attachment of “Sampling Plan of Acceptance Quality Level for Packaging Materials”, Annex. No. 01.
    • Samples for AQL inspection shall be collected throughout the selected number of boxes for sampling according to sample size and number of boxes/ containers. For example, in case of 125 number of samples which shall be collected from 6 containers, then 21 samples from each 5 containers and 20 samples from last 6th container.
    • The samples for AQL inspection shall be examined by QC personnel against the attachment of Acceptance Quality Level (Packaging Material), Annex. No. 02.
    • In AQL inspection, defects are classified in to three categories;
      • Critical Defects
      • Major Defects
      • Minor Defects
    • Observation of AQL inspection shall be reported in format of “Acceptance Quality Level Observation” Annex. No. 03.
    • If the number of defects found in the sample is equal to or less than the acceptance number, the lot/consignment shall be considered acceptable.
    • If the number of defects is equal to or greater than the rejection number, intimate the same to QC Head  for lot/ consignment failing in the acceptance quality level criteria, report the same with initiating the deviation and reinspect the lot/ consignment. For example, during AQL inspection, if lot size is 1300 then according to Annex. No. 01, designated sample size is 125 units, in case of minor defects is found 6 and as per Annex. No. 01, acceptance number is 5 and rejection number is 6. Thus the lot is rejected.
    • In case of re-inspection, use the same sampling plan and examine for the defects and if the number of defects is equal to or greater than the rejection number, then batch decision will be based in deviation closure.
    • Observation of AQL inspection of re-inspection shall be recorded in in format of “Acceptance Quality Level Observation” Annex. No. 01 with keeping remark by manually on the bottom left corner.

Leave a Reply

Your email address will not be published. Required fields are marked *

Related Posts