QMS Operational Procedure OP-74-03 VERIFICATION OF PURCHASED PRODUCT Eff. Date: 00/00/00 Rev.: 2 Pg. 1 of 4 I PURPOSE The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for verification of purchased product, and for performing receiving inspections of incoming product. II APPLICATION This procedure applies to the verification of purchased components (raw materials, substances, pieces, parts, software, firmware, labeling, or assemblies which are intended to be incorporated into the finished product). III PROCEDURE 1 Verification methods 1.1 All received components are subjected to a receiving inspection. The scope of this inspection includes verification of the identity and quantity of received product, a visual inspection to ensure that the product is not damaged or deteriorated, and identification of any documents delivered with the product. Instructions for carrying out this first-stage inspection are included in Section 2 of this procedure 1.2 Acceptance of components may be based solely on the first-stage receiving inspection, e.g., without any further verification, only when all of the following three conditions are met: Component is not critical to the safety of the product; Any defect of the component would likely become apparent in the course of production, assembly, or in-process or final inspections; There is full confidence in the supplier's quality system and product verification program (this may be based on the supplier's quality system certification, supplier audits, and satisfactory quality performance history). 1.3 For components that don't meet all the criteria listed above, one of the following additional verification requirements is specified: The supplier is required to provide evidence of product conformity, such as inspection, testing, or process control records, certificate of conformance, or certificates of analysis from an independent laboratory; or The component is subjected to in-house QC inspection and/or testing; 1.4 When purchased components are required to go through QC inspection or when they are supplied with quality records that must be evaluated and approved by QC, the purchase order indicates QC inspection requred. This is to inform receiving how to disposition these products. VERIFICATION OF PURCHASED PRODUCT Operational Procedure OP-74-03 Rev.: 2 Pg. 2 of 4 2 Receiving inspection 2.1 Upon unloading of deliveries, receiving counts the number of delivered units, checks marking and identification of packages, and inspects all packages for any signs of deterioration or damage. If all these checks and inspections are satisfactory, receiving signs the delivery receipt. If not, any shortages or damages are noted on all copies of the delivery receipts. 2.2 Next, the received packages are moved to the designated receiving area, a copy of the relevant purchase order is retrieved from the pending orders file, and the packing slips (if any) are removed from packages. Upon opening the packages, the products are counted, their part numbers (or other identification) are verified against the purchase order and the packing slip, and the products are examined visually for any signs of deterioration or damage. 2.3 Receiving also verifies that all requested quality records (if any), such as control charts, inspection/testing certificates, etc., are enclosed, or have been received in advance. 2.4 When the results of these inspections and verifications are satisfactory, the Receiving copy of the PO is dated, signed, and assigned a receiving number by receiving to establish a record of acceptance of the products. Rejected and accepted quantities are also noted on the PO. 2.5 If further QC inspections/evaluations are not required, receiving attaches a receiving label and the products are moved to appropriate material staging areas in production or are placed in a designated storage area. 2.6 If other product verification activities are required, for example, QC inspection or review of supplied product quality records, receiving attaches a green sticker by the receiving label and the products are moved, together with the receiving copy of the PO and any associated quality records, to the QC inspection area. 2.7 If a nonconforming product is identified, receiving initiates a nonconformity report in accordance with Operational Procedure OP-83-01, Control of Nonconforming Product. The product is labeled with a REJECTED sticker or tag, the nonconformity report number is marked on the sticker, and the product is moved to a designated (quarantine) area. In place of the REJECT sticker or tag, a copy of the NCR may be attached to the product. Copies of the nonconformity report are forwarded to Purchasing and Quality Assurance. 2.8 When the visual inspection is satisfactory but the required quality records are not available, the received products are labeled HOLD and are moved to a designated holding area. 3 QC inspection 3.1 Preparing for inspection and/or testing, the QC inspector assembles all relevant technical documentation, such as product specifications, test VERIFICATION OF PURCHASED PRODUCT Operational Procedure OP-74-03 Rev.: 2 Pg. 3 of 4 procedures, drawings, applicable standards and regulations, etc., that instruct how to perform the inspection or test, and provide the acceptance criteria. 3.2 As applicable, receiving QC inspection comprises: Review of material certificates, source inspection records, compliance certificates, and other such documentation delivered with the product; Random sampling based on statistical sampling plan specified; Visual inspection to detect any damage or other visible problems; Taking measurements and testing as required; and Recording the inspection/test results. 3.3 When products pass the inspection, the Receiving copy of the PO is dated and signed by the QC Inspector to establish a record of the inspection (there may also be additional inspection reports) and the inspector stamps the green sticker with their assigned inspection stamp. The products are moved to appropriate material staging areas in production or are placed in a designated storage area. 3.4 If products fail the inspection, the QC inspector removes the green sticker and initiates a nonconformity report in accordance with Operational Procedure OP- 83-01, Control of Nonconforming Product. The product is labeled with a REJECTED sticker or tag, the nonconformity report number is marked on the sticker, and the product is moved to a designated (quarantine) area. In place of the REJECT sticker or tag, a copy of the NCR may be attached to the product. Copies of the nonconformity report are forwarded to Purchasing and Quality Assurance. 4 Source inspection 4.1 Where purchased product verification is to be performed or witnessed at the supplier's location, the arrangements and method of product acceptance are specified in purchasing documents. This also applies to cases where source inspections are performed or witnessed by customers. 5 Acceptance/inspection records 5.1 Records of acceptance of products are established by signing and dating the Receiving copy of the PO. After products are inspected visually by receiving, the PO is signed and dated by receiving. For products that are also inspected by QC, the PO is additionally is signed and dated by the QC inspector. 5.2 The Receiving copies of POs that are only signed by receiving (e.g., no need for QC inspection) are stored and maintained by Receiving. 5.3 The Receiving copies of POs that are also signed by the QC inspectors, as well as associated inspection reports (if any), are stored and maintained by Quality Assurance. VERIFICATION OF PURCHASED PRODUCT Operational Procedure OP-74-03 Rev.: 2 Pg. 4 of 4 5.4 At a minimum, acceptance and inspection records include the following information: Identification of the product and its manufacturer/supplier, Acceptance activities performed (may be documented in procedures, work instructions or specifications instead of inspection records), The results and quantities accepted and rejected, Identification of measuring and testing equipment used (where appropriate), and Date and signature of the individual conducting the acceptance activities. When a copy of the PO is used as a base for establishing the record, most of this information is already on the PO, and thus the person establishing the record needs only to indicate quantities accepted and rejected, and sign and date the record. 5.5 When traceability is required for the purchased product, the acceptance/receiving inspection records are linked to the actual products in which the components are used. IV ASSOCIATED DOCUMENTS Operational Procedure OP-74-02, Purchasing Operational Procedure OP-83-01, Control of Nonconforming Product Specifications for purchased materials, components and subassemblies (acceptance criteria) Work Instructions: QC inspection and test procedures V ASSOCIATED RECORDS Receiving inspection records: Copies of POs, packing slips, etc., signed off by receiving as evidence that the received products passed the visual receiving inspection. Supplier furnished records: Process control charts, inspection/testing reports, certificates of compliance, and other such evidence of product conformity that are supplied with the purchased product. QC inspection/test records: Records of QC inspection/testing of incoming product.