Quality Control Instruction WI Number # ISSUE: QCI-WIL-007 Total # Pages Page No. # 01/09/14 1 4 LABELING REQUIREMENTS FOR HS PUMP SERIES PROPRIETARY NOTICE *This document contains proprietary information and such information may not be disclosed to others for any purpose without written permission. PREPARED BY: Marco Robles APPROVED: DATE: 01/09/2014 DATE: Javier Tril 01/09/2014 REVISION RECORD ISSUE DATE PAR. NO. DESCRIPTION CHECKED BY: 01/09/14 N/A New release Marco Robles APPROVED BY: Javier Tril ALL PRINTED COPIES OR REPRODUCTIONS OF THIS DOCUMENT ARE “UNCONTROLLED” AND SHALL BE UTILIZED FOR REFERENCE ONLY. Form # 06Q103 Issue: 06/03/13 Quality Control Instruction WI Number # ISSUE: QCI-WIL-007 01/09/14 Total # Pages Page No. # 2 4 LABELING REQUIREMENTS FOR HS PUMP SERIES 1. PURPOSE: 1.1. This document is to define the packaging requirements for suppliers of Wilden components to comply with articles 15 and 17 of EN 1935-2004 specification. 2. SCOPE: 2.1. This QCI is applicable to the following departments and/or suppliers that provide product to be incorporated in the assembly of HS pumps. 4000 Purchasing 4010 Receiving 6000 Quality Control 3116 Material Handling Suppliers 3. DEFINITIONS: 3.1. EN 1935-2004: Technical specification developed by the European parliament and the council of the European Union to outline the requirements for materials and articles intended to come in contact with food. 4. RESPONSIBILITIES: 4.1. It is the responsibility of the purchasing personnel to communicate these requirements to all applicable suppliers. 4.2. It is the responsibility of the supplier to provide packaging and identification of supplied goods as outlined by this document. 4.3. It is the responsibility of QC department to verify compliance to this document and to take any necessary actions when suppliers fail to adhere to this document. 4.4. It is the responsibility of all receiving and material handling personnel to the notify QC department, when failure to meet compliance to this document is observed. 4.5. In the event of conflict between this QCI and the purchase order, it is the responsibility of the supplier to request clarification prior to order acceptance. 5. PROCESS: 5.1. Product identification: 5.1.1. All products shall be bagged and tagged as per package quantities specified on purchase orders using labels “A” and “B” and placed inside the shipping container (e.g. cardboard box). Shipping container shall be externally labeled using labels “A” and “B”. 5.1.2. Label “A” provides immediate product traceability required by paragraph 5.2. The following requirements for label “A” shall be met: 5.1.2.1. Label Size: – 4” x 5” Thermal Transfer Label. 5.1.2.2. Part Number: – S-7419 from U-line, or equivalent. 5.1.2.3. Printer Brand and Model: – Zebra, TLP-2844. 5.1.2.4. Label Matrix: – Teklynx V8.10.02. ALL PRINTED COPIES OR REPRODUCTIONS OF THIS DOCUMENT ARE “UNCONTROLLED” AND SHALL BE UTILIZED FOR REFERENCE ONLY. Form # 06Q103 Issue: 06/03/13 Quality Control Instruction WI Number # ISSUE: QCI-WIL-007 Total # Pages Page No. # 01/09/14 3 4 LABELING REQUIREMENTS FOR HS PUMP SERIES 5.1.2.5. Bar code symbology: 3 of 9 (Code 39) 5.1.2.6. Items to be listed on label in the following order: 5.1.2.6.1. Part Description: 5.1.2.6.2. Our Issued Vendor Number: 5.1.2.6.3. Part Number w/barcode: 5.1.2.6.4. P.O. Number w/barcode: Font: Arial/18 Font: Arial/18 Font: Arial/45 Font: Arial/22 **NOTE: PO Number shall be set-up using a “Zero” [0] instead of letter “O”. 5.1.2.6.5. In box quantity w/barcode: 5.1.2.6.6. Lot Number: Font: Arial/22 Font: Arial/16 Label “B” 5.1.3. Label “B” displays the symbol introduced by the commission directive 80/590/EEC (2) to provide clear identification of materials or components intended to come in contact with food, or any other edible media intended to be incorporated or converted into food. The label size may be determined by each supplier using best fit criteria for label to be applied in the upper right corner of label “A”. 5.1.3.1. Optional: Suppliers have the option to print the “glass and fork” symbol introduced by the commission directive 80/590/EEC (2) directly on label “A” as a substitute of having both labels; this is at the discretion and capabilities of each supplier. ALL PRINTED COPIES OR REPRODUCTIONS OF THIS DOCUMENT ARE “UNCONTROLLED” AND SHALL BE UTILIZED FOR REFERENCE ONLY. Form # 06Q103 Issue: 06/03/13 Quality Control Instruction WI Number # ISSUE: QCI-WIL-007 Total # Pages Page No. # 01/09/14 4 4 LABELING REQUIREMENTS FOR HS PUMP SERIES 5.2. Raw Material Traceability: 5.2.1. Supplier shall provide means for traceability of the product label to all materials and objects incorporated into the manufacturing of components referenced and governed by this QCI. Such traceability must be maintained at all stages of production and distribution in order to facilitate proper monitoring; and when necessary the withdrawal of possible defective products, consumer information and the attribution of responsibility. Product traceability includes but is not limited to the following: 5.2.1.1. Material Type or specification. 5.2.1.2. Material batch, lot or heat number. 5.2.1.3. Material Supplier/s. 5.2.1.4. Supplier work orders. 5.3. Package labeling: 5.3.1. Supplier shall evaluate and select the best suitable packaging materials to prevent product damage and contamination during transportation (ref: QCI-WIL-006). The packages must be identified as specified on section 5.1 of this document. In the event that supplier cannot determine appropriate packaging, it is the supplier responsibility to contact the Wilden representative to determine best packaging method. All packages shall include but are not limited to the following: 5.3.1.1. Labels affixed to each individual bag, when parts are individually bagged and tagged. 5.3.1.2. Labels affixed to each individual box, including the box sequential number as 1 of 3, 2 of 3, and so on. 5.3.1.3. Master label affixed to the pallet, including the total of boxes within the pallet, and pallet sequential number as “pallet 1 of 3, 2 of 3, and so on”. 6. REFERENCE DOCUMENTS: 6.1. EN 1935-2004 - Specification for materials and articles intended to come in contact with food. 6.2. POCD-001-a - Required packaging label information. 6.3. QCI-WIL-006 - HS Pump Components Packaging ALL PRINTED COPIES OR REPRODUCTIONS OF THIS DOCUMENT ARE “UNCONTROLLED” AND SHALL BE UTILIZED FOR REFERENCE ONLY. Form # 06Q103 Issue: 06/03/13