SOP-169-001: Standard Operating Procedure for Raw Material Inspection and Acceptance
1. Purpose
1. 1 This Standard Operating Procedure (SOP) outlines the procedure for inspecting and accepting
raw materials used in the manufacturing of printing inks at Kolora Ink and Chemical Corporation.
2. 2 The purpose of this SOP is to ensure that all raw materials meet specified quality standards
before being released for production, thereby preventing the use of non-conforming materials
that could compromise the quality and performance of finished ink products.
2. Scope
2. 1 This SOP applies to all raw materials received at Kolora Ink and Chemical Corporation,
including but not limited to pigments, resins, solvents, additives, and other chemical
components used in ink manufacturing.
3. 2 This SOP covers the receipt, inspection, sampling, testing, and acceptance or rejection of raw
materials.
3. Responsibilities
3. 1 Receiving Department: Responsible for receiving raw materials, verifying the quantity against
the purchase order, and ensuring proper documentation.
4. 2 Quality Control (QC) Department: Responsible for inspecting, sampling, testing, and
approving or rejecting raw materials based on established specifications.
5. 3 Warehouse Personnel: Responsible for storing raw materials under appropriate conditions
and maintaining accurate inventory records.
6. 4 Purchasing Department: Responsible for ensuring that raw materials are procured from
approved suppliers and that all necessary documentation is provided.
4. Definitions
4. 1 Raw Material: Any substance or component used in the manufacturing of printing inks.
5. 2 Specification: A detailed description of the required characteristics and properties of a raw
material.
6. 3 Certificate of Analysis (COA): A document provided by the supplier that certifies the quality
and purity of a raw material.
7. 4 Acceptance Criteria: The specific requirements that a raw material must meet to be approved
for use.
8. 5 Non-Conforming Material: Any raw material that does not meet the specified acceptance
criteria.
5. Procedure
5. 1 Receipt of Raw Materials
o 5. 1. 1 Upon arrival of a raw material shipment, the Receiving Department shall:
o Verify the quantity of each item against the purchase order and packing list.
o Inspect the condition of the packaging for any signs of damage or
contamination.
o Record the date of receipt, supplier name, material name, lot number, and
quantity received in the receiving log.
o Assign a unique internal identification number to each received lot.
o Affix a receiving label to each container with the material name, lot number,
internal identification number, and date of receipt.
o 2 Notify the QC Department that a raw material shipment has
been received and is ready for inspection.
1. 2 Inspection and Sampling
o 5. 2. 1 The QC Department shall:
o Review the Certificate of Analysis (COA) provided by the supplier to verify that
the material meets specifications.
o Inspect the material visually for any signs of non-conformity, such as
discoloration, clumping, or foreign matter.
o Collect a representative sample of the raw material using appropriate sampling
techniques to ensure the sample is representative of the entire lot.
o Record the sampling date, time, and location in the sampling log.
2. 3 Testing
o 5. 3. 1 The QC Department shall perform the following tests on the raw material sample,
as applicable:
o Appearance: Visual inspection for color, clarity, and uniformity.
o Identification: Verify the identity of the material using appropriate analytical
techniques (e.g., FTIR, GC-MS).
o Purity: Determine the purity of the material using appropriate analytical
techniques (e.g., HPLC, GC).
o Moisture Content: Measure the moisture content using a moisture analyzer.
o Viscosity: Measure the viscosity using a viscometer.
o Particle Size: Determine the particle size distribution using a particle size
analyzer.
o Color Strength: Measure the color strength using a spectrophotometer.
o Other Tests: Perform any other tests specified in the material specification.
o 2 Record all test results in the raw material testing log.
1. 4 Acceptance Criteria
o 5. 4. 1 The raw material shall be accepted if it meets all of the following criteria:
o The COA from the supplier indicates that the material meets specifications.
o Visual inspection reveals no signs of non-conformity.
o The test results obtained by the QC Department meet the acceptance limits
specified in the material specification.
1. 5 Acceptance/Rejection Decision
o 5. 5. 1 Based on the inspection and test results, the QC Department shall:
o If the raw material meets all acceptance criteria, approve the material for use
and record the approval in the raw material testing log.
o Affix an "Accepted" label to each container of the approved material, indicating
the date of approval and the signature of the QC personnel.
o If the raw material does not meet the acceptance criteria, reject the material
and record the rejection in the raw material testing log.
o Affix a "Rejected" label to each container of the rejected material, indicating the
date of rejection and the reason for rejection.
o Notify the Purchasing Department and the supplier of the rejected material.
2. 6 Handling of Non-Conforming Materials
o 5. 6. 1 Non-conforming raw materials shall be:
o Quarantined in a designated area to prevent accidental use.
o Returned to the supplier for replacement or credit, as agreed upon with the
Purchasing Department.
o Disposed of in accordance with applicable environmental regulations, if return
to the supplier is not possible.
o Documented in a non-conformance report, including the reason for rejection,
the quantity rejected, and the corrective action taken.
3. 7 Storage of Accepted Raw Materials
o 5. 7. 1 Accepted raw materials shall be stored in the warehouse under appropriate
conditions, as specified in the material safety data sheet (MSDS) and the material
specification.
o Store materials in a clean, dry, and well-ventilated area.
o Maintain appropriate temperature and humidity levels.
o Protect materials from direct sunlight and other sources of heat or radiation.
o Store hazardous materials in accordance with applicable safety regulations.
o 2 Maintain accurate inventory records of all raw materials in the
warehouse.
o 3 Use the First-In, First-Out (FIFO) method for inventory rotation to
ensure that materials are used before their expiration date.
6. Documentation
6. 1 The following documents shall be maintained as part of this SOP:
o Raw Material Specifications
o Purchase Orders
o Packing Lists
o Receiving Log
o Sampling Log
o Raw Material Testing Log
o Certificates of Analysis (COAs)
o Non-Conformance Reports
o Material Safety Data Sheets (MSDS)
o Inventory Records
7. Training
7. 1 All personnel involved in the raw material inspection and acceptance process shall be trained
on this SOP.
8. 2 Training shall be conducted by qualified personnel and documented in the training records.
9. 3 Training shall be repeated periodically to ensure that personnel remain proficient in the
procedure.
8. Revision History
Reason for
Revision Number Date of Revision Approved By
Revision
01 [Date] Initial Release [Name]
9. Approvals
Prepared By:
[Name]
[Title]
Date: [Date]
Reviewed By:
[Name]
[Title]
Date: [Date]
Approved By:
[Name]
[Title]
Date: [Date]
This SOP is a template and should be customized to fit the specific needs and requirements of Kolora Ink
and Chemical Corporation.