In-process and Final Inspection PDF

Page 1 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and...

Page 1 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 1. Purpose: The purpose of this document is to define workmanship standards and the methodology for performing inspections on product being manufactured at Putnam Plastics. 2. Scope: 2.1. This document applies only to Production and Development parts (except those in the Filmcast Department where the Filmcast In-Process and Final Inspection Work Instruction DMS #6126 applies). Additionally, any specific requirement called out in the reference documents listed below shall supersede any overarching requirement called out in this document. 2.2. This document applies to any personnel involved in the inspection and/ or testing of manufactured product. 2.3. Inspection and test requirements as listed in this work instruction will be determined by the Customer Specification/ requirements, by Quality, and/or by Engineering, and will be identified in the Quality Inspection Plan (QIP) and/ or Device Assembly Work Instruction for Production items. Inspection and test requirements for Development will be determined by the Customer Specification, QIPs, and/or OQVS requirements and will be documented in the Quality Inspection History Form. 3. Responsibilities: 3.1. Director of Quality and Regulatory Affairs: or designee is responsible to revise this document as required. 3.2. Employees performing test or inspection are responsible to ensure compliance with this work instruction for the product being manufactured. 4. Reference Documents and Forms: 4.1. Product Scope Reading Form 3 (DMS#1252) 4.2. Hot Piece Shrinkage/Growth Record (DMS#1253) 4.3. Product Scope Reading Form 1(DMS#1254) 4.4. Product History Form 7 (DMS#1264) 4.5. Guidewire Product History Form (DMS#015715) 4.6. Burst pressure Procedure for Crescent Hydraulic Burst/Leak Tested Mod 1000 (DMS#1152) 4.7. First Article Report (DMS#1255) 4.8. Quality Inspection History Form (DMS#2531) 4.9. Control of Non-Conforming Product (DMS#1018) 4.10. Gage Pin Work Instruction (DMS#1166) 4.11. Line Clearance Procedure (DMS#1288) 4.12. Quality Inspection Plan Work Instruction (DMS#1160) 4.13. Operations of the Vision System (DMS#1866) 4.14. Magnification for Use of the Vision System (DMS#1867) 4.15. Operation of the Quadra-Check 200 Vision System (DMS#1881) 4.16. Sampling Plans and Systems (DMS#6473) 4.17. M3 Metrology Software use on Starrett Scopes (DMS#015802) 4.18. Verifying Braided and Coiled Patterns (DMS#3543) Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 2 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 4.19. Verifying Requirements Prior to shipping (DMS#1141) 4.20. Issue and Control of Production and Inspection Stamps (DMS#6380) 4.21. Tensile / Elongation Procedure (DMS#1155) 4.22. In Process and Shipping Audit (DMS#1242) 4.23. TriLayer Melt Pressure Record (DMS# 017152) 5. Definitions: 5.1. IPA: Isopropyl Alcohol 5.2. OD: Outside diameter of a tube or component. 5.3. ID: Inside diameter of a tube or component. 5.4. Roundness/Circularity: Form of a diameter, either OD or ID. Indicated on drawings with the symbol “O” Radial (on radius) distance between concentric sections of a diameter (minimum and maximum) 5.4.1. At PPC ovality measurement is usually used to estimate the roundness, and it is 2x roundness specification given on drawing (e.g., if you see on a drawing the ovality would be 0.50) 5.5. Ovality: [ODmax - ODmin=Ovality] 5.6. Concentricity: Denoted with the symbol. This is most commonly measured as a variation of the wall thickness around the circumference of a tube or component, shown as a percentage. Calculated as [(WALLmin / WALLmax) *100=%; alternatively, it may be also calculated as WALLmax - WALLmin]. 5.7. Curvature: The amount a specific component deviates from 180° of straight. Measured as the apex of the component when the two opposing ends are against a parallel plane (also known as “bow”). Part Gauge pin (or scale) Parallel 5.8. Cut Perpendicularity: A measure of how perpendicular or square the cut plane of a part is to its longitudinal axis. Usually measured in degrees (measured from the longest section to the shortest section of the cut). Designated on drawings using the GD&T symbol “┴”) 5.0° 5.9. TAPPI: A standard size estimation chart for spots, gels and particulate. Straight lines represent same area as the dots. 5.10. Laser Micrometer: A calibrated device that uses a laser beam sweep across a fixed window to measure the distance of the outer edges of parts placed within the window. 5.11. Wall Thickness: The amount of material of a component as measured from the inside diameter to the outside diameter (thickness of the cross section). 5.12. 5P: QAD internal part numbering system that uses a 5P prefix for all part numbers. 5.13. Min: (Minimum) 5.14. Max: (Maximum) Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 3 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 5.15. Nom: (Nominal) 5.16. Lumen: The inside diameter of an extruded tube 5.17. Multi lumen: A component that has more than 1 lumen 5.18. Bump/taper: A component that has more than one inside and/or outside diameter with transitional areas or lengths that link them together. 5.19. Pin gauge: A hardened cylindrical gage used to inspect the size of a hole (known as a plug gauge or gage pin). 5.20. Best Fit Pin Gauge: Refers to fitting a pin gauge into the ID of a part or component that will fill the ID without expanding or distorting the OD. 5.21. Durometer: The measure of the hardness of a polymer. Most common are the Shore “A” and Shore “D” designations, preceded by a numerical value (i.e., 80A or 35D).  Note that the “D” scale is harder than the equivalent “A” scale value (65D > 65A).  These scales overlap (90A is equivalent to approximately 40D). 5.22. Tensile Strength: Maximum stress a material can withstand while being stretched or pulled before failing or breaking 5.23. Elongation: the increase in a stretched sample’s length measured after breaking divided by the sample’s original length. The greater the elongation, the higher the ductility or elasticity of the sample. 5.24. Quality Inspection Plan: A plan that details the inspection and / or test requirements for a manufactured product. 5.25. AQL – Acceptance Quality level, defective percent. 5.26. PQC or Post QC – Post Quality Control where the inspection of a given lot/process is completed. Used interchangeably with “Final Inspection”. 5.27. In Process Inspection: Quality Control checks performed while the product is still being produced. These may apply towards the required sampling. 5.28. Final Inspection: where the inspection of a given lot/process is completed. Used interchangeably with Post QC. 5.29. LHR: Lot History Review – where the lot documentation is completed and reviewed following the completion of inspection.  Note: Any changes to definitions should be compared for consistency to those on the Quote Template (DMS #015937). 5.30. Target dimension: reference dimension for production control. 5.31. Reference dimension: dimension which is non-rejectable. 6. Safety Precautions: Follow all required safety precautions in the area inspection or testing is being performed. 7. Process: 7.1. General 7.1.1. Line clearance of inspection tools must be performed per Line Clearance Procedure (DMS#1288) and documented on the Quality History Form (DMS#2531) or the designated Quality Inspection Plan if applicable by the Quality Inspector at the onset of In-process and Final Inspection. 7.1.2. Inspection is to be performed with calibrated instruments and/or gauges. If the instrument is found out of calibration or not calibrated it shall be returned to the Calibration Technician or their designee. Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 4 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 7.1.3. All quality inspectors and/or operators shall use the following instruction:  The quality inspector and / or operator shall inspect the product with the customer’s specification and / or quality inspection plan (QIP) requirement and record results on the appropriate inspection record.  Due to the nature of some materials, the dimensions may change after the extrusion process. It is acceptable to collect product to an offset dimension if it is being reviewed for dimensional change over time using Hot Piece Shrinkage/Growth Record (DMS#1253). 7.1.4. Inspection / testing requirements listed in this work instruction shall be followed unless otherwise specified by any of the following:  The Customer Requirements  Directory of Quality and Regulatory Affairs and/ or Quality Engineer  Deviations 7.1.5. Inspection data that does not meet specification shall be shaded in the upper right-hand corner.  A Non-conformance shall be written for production items not meeting the specifications stated in the Quality Inspection Plan (QIP).  A Non-conformance may be written for items produced on development work orders that do not meet specifications. Quality will consult with a Subject Matter Expert NPD or Manufacturing/Process Engineer to determine if the NC is appropriate. Non-conformance found in Development product may be dispositioned as OK to ship by the Subject Matter Expert NPD or Manufacturing/Process Engineer and/or Technical Sales. This would be documented by signing the inspection record indicating the lot is OK to ship. 7.1.6. Inspection and Testing:  All products being manufactured are to be inspected on a regular basis to ensure compliance to the specification by Quality Control, the operator or designated resource, if needed.  Inspection data is to be recorded on the appropriate forms or data sheets.  If the nature of the product being manufactured does not allow for the operator to be free to perform regular checks, i.e., walk outs, hand unload, etc.; notify the supervisor or designee to obtain the resources needed to perform the inspection on a timely basis.  Product passing inspection goes to LHR In-process Inspection  Minimum inspection criteria that will be used for all extruded tubing, when not specified by the customer, is to measure o 2 out of the 3 dimensions the wall, ID, or OD (preferably wall & OD except solid profiles are OD only). Inspection o Wall concentricity (minimum beginning, middle and end of lot). Requirements o Ovality (minimum beginning, middle and end of lot). o Length o Curvature (minimum beginning, middle and end of lot). o Cut quality o Visual including color Inspection of  After “sizing” step is completed the operator takes 1 piece and measures and records all required Extruded dimensions Products – Cut  If product is in specification, then QC inspector takes 2 more pieces and measures and records all Online required dimensions Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 5 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021  Calculate the number of samples required to meet the AQL during the run. Spread sampling evenly over run time. If sampling size is not met during the run, then it is finished at PQC.  Sample must be identified by bag #, layer #, or spool # to simplify segregation product if necessary, whenever possible  Record on inspection form  Do not move to next manufacturing step until QC clearance is received or inspection is completed to avoid “running at risk”  At the end of the lot a minimum of 2 pieces must be measured and recorded by QC inspector.  On the first spool the operator takes 1 piece and measures and records all required dimensions.  If product is in specification, then QC inspector takes 2 more pieces and measures and records all required dimensions  It is acceptable to use the end of spool data for another spool’s beginning only if the product is being collected in series without changes to process. Inspection of  On subsequent spools take 3 samples from end of each spool. For TriLayer do one (1) scope ratio Spooled Product concentricity wall check per spool  Ensure that the product is wound uniformly across and does not have valleys or sinks at the flanges of the spool.  Product should be wound with enough tension as, so it does not pull down into the windings and when being unspooled. Inspection of  A minimum of 3 samples at the beginning of a lot and two samples at the end of a lot will be inspected product that is  For every 30 minutes of collection time, between 1 and 3 samples must be inspected. cut to final length in-line:  Attribute Sample Sample DMS Record # Size size extrusion cutting O.D. 100% 100% monitor monitor on-line on-line laser laser 2531 I.D. 1 pc N/A beginning and 1 pc end of spool Tri-layer Length N/A 1pcs per Product 500 pcs Delamination 1pcs Wall Concentricity beginning Wall Thickness. and 1 pc N/A Wall Ratio end of spool Visual/surface 1pcs 100% beginning and 1 pc end of spool Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 6 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021  TriLayer Delamination Test - Cut tubing at approximately a 45-degree angle with a razor blade. View the cut section of the tube under enough magnification to clearly see the side wall. There should be no visual evidence of separation. Use the point of the razor to attempt to gently separate the layers while viewing under magnification. The layers should not easily separate. Review with supervisor or engineering if questions arise. Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 7 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 In-process Product Disposition If product  The product and work order packet will then be moved to Post QC. passes all  Samples must be identified by sample number that corresponds to the Inspection Record checks entries. Inspection Types Wall Thickness The wall thickness specification of a tube is the average of a minimum 4 readings taken at equal distances around the part circumference unless stated in the quality plan that all points must conform. The following are the minimum concentricity levels based on the nominal wall thickness of the part If a wall thickness is not specified or implied on drawing, calculate the nominal condition as [(ODnom - IDnom)/2=Nominal Wall] Overall Nominal Wall Thickness Minimum Concentricity Concentricity ≤0.001” 65% >0.001” to ≤0.003” 75% >0.003” to ≤0.005” 85% >0.005” to ≤0.030” 90% >0.030” 92% The OD specification for tubing is an average unless otherwise stated in the specification and/or Quality Inspection Plan.  The measurement method for this is a single axis laser with a rotating chuck, 8 points, unless another measurement method is specified. OD Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 8 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021  Microscope measurements for the OD use a minimum of 6 points  For flexible or thin-walled tubing that cannot be supported by the laser gauge chuck, measure the OD with a best fit pin gauge inserted into the part. . The maximum Ovality condition for tubing is 100% of the overall tolerance of the OD.  As an example, the tolerance for a tube is ±0.003”, the maximum Ovality condition is 0.006”.  If the OD is a referenced dimension, the maximum Ovality condition will use the Ovality overall tolerance for the ID (Inside Diameter), using the same method as the shown for the OD Note: For Multi-lumen tubing the maximum allowable Ovality condition needs to be addressed on an individual case by case basis due to the inherent complexity level. Pin: When using gage pins to inspect IDs, follow instruction and guidelines stated in Gage Pin Work Instruction (DMS#1166) and remove below. Note: When measuring ID on products produced with a skin, the ID must be measured both at the time of extrusion (with the skin on) and after skin removal. Record both results. ID  For pieces cut too short in length to measure ID, a separate ID samples may be measured and retained. Note: Some polymers induce a great deal of surface tension making it difficult to insert a pin gauge no matter the size. It is acceptable to “wet” the surface of the pin gage with IPA in these instances to reduce surface tension.  Examples of this (not all inclusive) are most low durometer polyurethanes (≤90A durometer), Cflex and Pebax ≤40D grades.  When using IPA, use care to remove the portion of the tubing exposed to IPA before taking additional readings or storing the sample to prevent any chemical reaction that may change the tubing. Microscope:  When measured with a microscope ensure the sample preparation does not deform the part.  Microscope measurements for the ID will use a minimum of 6 points unless otherwise specified by the Quality Inspection Plan or Product Specification. Maximum Curvature for Rigid single lumen tubing (capable of retaining their shape post extrusion). Examples of rigid and semi rigid tubing (list is not all inclusive):  Pebax 55D, 63D, 70D, 72D Pebax  Nylon  High durometer Hytrels Curvature  LDPE, MDPE, HDPE, Polypropylene  Polyurethane or PVC >90A durometer  PEEK  Polysulfone  Ultem For parts > 6” length, the maximum allowable curvature is ≤15% of the overall length [(LENGTHnom×0.15) = CURVATUREmax]. Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 9 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 For parts ≤ 6” length, the maximum curvature is 1/4”. Parts that are cut from spools are exempt from this requirement. Use the following table when viewing end cut quality. Cut Quality Table 1. View by: Acceptance Criteria  End cuts must be square  No fraying or strings hanging on the ends Unaided eye at 12-18”  Ends not deformed or grossly out of round (Corrected to normal vision)  No “creasing” or folding of the part ends  No splits or shattering of the part ends Below are examples of nonconforming end cuts. The Quality Inspection Plan will detail the requirements for end cut quality. If the Quality Inspection Plan does not have an end cut requirement, Table 1. Shall be used. End cut caused deformation End cut caused roughness  Sampled at 12”-18” with the unaided eye under normal lighting conditions unless stated on the product QIP or specification that magnification is required. Inspect for a maximum 10 seconds per part. o No more than 2 included objects (gels, contamination) >.10 mm2 per foot, as per the TAPPI standard (T-564) Visual and  The following is a list of typical visual characteristics that may be observed. Following Color the requirements of the QIP for the part being inspected. If in doubt, see your supervisor or responsible engineer. The photos below are intended only to show examples of how these may appear and should not be considered as limit samples. These may include:  Gels (fisheyes) – these are small area where the raw material melted differently (see picture below). These may be round as in the picture or elongates and appear as a Fish’s eye.  Die lines or flow lines – small axial lines down the entire length of the part  Scratches – random pattern or individual scratches that appear on the surface (see photo below)  Chatter marks – repeating marks generally down the entire length of a tube caused by rubbing a surface (see picture below) Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 10 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021  Nibs – common term for small bumps on the surface (see photo below)  Water spots – residue left behind from cooling water that did not blow off in the air wipe (see photo below) Gels / Fisheye Scratches (magnified) Chatter marks (magnified) Nibs Water spot o No loose particulate such as dirt, hair, threads, or fibers Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 11 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021  Color must match the call out on QIP. Pantone shall be in accordance with the customer specification if specified.  Color should be consistent throughout the lot. As samples are collected, review the group of samples for consistent color. If there is a question or concern, contact your supervisor. Braided and Coiling Pattern See Verifying Braided and Coiled Patterns (DMS#3543). inspection See Tensile/ Elongation Test (DMS#1155)  Follow QIP requirements for this test. Tensile /  Record as required. Elongation o Note: Printed report from testing machine will suffice as the record to show conformance for the lot history record See Burst pressure Procedure per Crescent Hydraulic Burst/Leak Tested Mod 1000 (DMS#1152) or Burst AngioDynamics Static Pressure Testing TM004 (DMS#2831)  Record on inspection record as appropriate. Hot Piece Shrinkage / Growth Verification  The quality plan or NPD engineer will determine when a Hot Piece is required. General Notes  All Hot Piece checks will be recorded on Hot Piece Shrinkage/Growth Record (DMS# 1253). Spooled Product  A separate spool will be provided (approximately 100’) for QC to conduct hot piece study  Un-wrap approximately 5 turns of the spool for samples. On-line Product  Take two full lengths of tubing from the production line. For items where the length of the part being produced prevents the use of a full-length piece, a shorter sample may be substituted. That shorter samples would then be monitored for any change in length that may occur.  Use same methods and equipment that will be used for post QC  On piece one, measure the overall length record the results.  On piece two, measure the ID on one end and record the results.  On piece two, measure the OD on the opposite end and record the results.  The pieces in the hot piece study should be re-measured until growth/shrinkage appears to stabilize over 3 readings taken over 3 hours. o Note: It may be necessary and is acceptable to inspect additional samples if the specified Measurements tubing has different geometries on either end of the tube (i.e.., tapered tubing, multi-lumen.)  If the dimensions have shifted to be out of the specified tolerances, the appropriate changes are to be made and collected product is to be discarded. The process of verifying the hot piece will start over once the adjustments are made. Final Inspection Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 12 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021  Product will be inspected using C=0 Sampling Plan, Acceptable Quality Level 2.5, unless the customer or QIP requires a different sampling plan. o For C=0 Sampling Plans refer to the Nicholas L. Squeglia Table 1a o For ANSI and Mil Spec sampling requirements use the AQL Inspector’s Rule ANSI/ASQ Z1.4-2003 (R2013) And MIL-STD-105E o For ISO Sampling Requirements use the AQL Inspector’s Rule ISO 2859-1 (1999)  Samples need to be random and distributed throughout the lot  If the AQL requirements for final inspection are met during in-process inspection, no additional inspection is required.  If dimensions change due to shrinkage/growth, then full re-inspection may be required. Check with supervisor or designee to determine if a full re-inspection be done if hot piece shows change.  The samples from in-process inspection can be applied to final AQL sample size requirements for the attribute being inspected /tested.  Samples recorded must be identified by bag #, layer # and/or spool # to the greatest extent possible to simplify segregation product if necessary.  Record on inspection form. Sample Size Requirements  Spooled Product o Take one 3-foot sample from the end of each spool.  Note: Customer sample size requests will be used in lieu of the 3- foot sample. o Inspect / Test each sample per QIP / customer Specification.  Tri-layer Product Attribute Sample Size* Record # O.D. I.D. AQL 2.5 C=0 Length 2531 Delamination Concentricity AQL 10 C=0 Wall Thickness Wall Ratio * Unless otherwise specified by the customer. Packaged  Visual inspection at 12”-18” with the unaided eye under normal lighting. Target maximum 5 seconds Product per bag. Note: More time may be needed for long product.  No more than 2 particles >.20 mm2 per bag as per the TAPPI standard (T-564).  Bag(s) must be free of holes.  Bag(s) must be completely sealed. If product is double bagged care must be taken to insure that bags a are not sealed together. Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15  Page 13 of 13 Document Revision: Document Name: Number Effective Date: 1151 18 In-process and Final Inspection 4/7/2021 Note: Specks imbedded in bags will not require rejection unless they are determined to be excessive by the Quality Control Manager or designee.  Shade in the upper right-hand corner of the non-conforming data and notify the Quality Manager or designee. Non- conforming  For any product that does not meet the requirements, follow Control of Non-Conforming Product (DMS# 1018) Product  Quality Manager or designee will notify Business Unit Leaders, and/or supervisor for any non-conformance. 8. Revision History: Revision Number Date Explanation Including Change Number If Applicable 14 11/17/17 Added Packaged Product Requirement to Final Inspection section. 15 3/1/18 Modified scope to address AI-492 16 Updated TriLayer inspection and delamination test, added definitions and updated Cut Quality 12/6/19 Section 17 Updated the first bullet point in section 7.1.5 for clarification on the conditions in which to open a 2/19/21 non-conformance. Revised section 7.1.5 to state that SME Manufacturing or Process Engineer along with Tech sales, 18 3/29/21 can approve nonconforming development product for shipment by signing Inspection record indicating the lot is ok to ship and removed OQVS reference in 7.1.5 1st bullet. Previous Revisions See revision history file in Document Control Proprietary and Confidential This Document includes proprietary and confidential information which is to be maintained in strict confidence. Reproduction, use or disclosure without express written authorization is prohibited Property of Putnam Plastics Corporation and its associated departments. General Work Instruction Template – #2419 Rev 4 Effective Date: 10-07-15