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Product Protocol

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PROTOCOL APPROVAL PAGE

PROTOCOL # | PRC TBD | REVISION: | A | DATE: | Dec 2009 | COMPLETION REPORT # | PRC TBD | MASTER VALIDATION PLAN # | NA | | | | | TITLE: Houdini/ACE Packaging Inquiry Transfer | | TYPE: Product Inquiry Transfer | | PROJECT NAME: Houdini | | PROJECT LEADER: TBD | | Product Code: TBD Product Number: Batch Number: NA ORIGINATOR NAME: | TBD | EXTENSION: | TBD | TITLE: | Quality Engineer | SITE: | | APPROVAL STATUS: Review & Approval Status (Priority or Normal): | | | Status | Approval Due Date: | | | Due Date | APPROVAL LIST: FUNCTION | NAME (PRINT) | SIGNATURE | DATE | DISPOSITION (ACCEPT/REJECT) | Independencia QS Manager | | | | | Albuquerque QS Manager | | | | | Customer Complaint Manager | | | | | Energy BU Manager | | | | | Regulatory Reporting Specialist | | | | | Customer Quality Packaging Engineer | | | | |

DISTRIBUTION LIST: (create as necessary) 1 Note: For Sedation Systems approvals, an electronic approval page will be generated in place of the hardcopy signature page (reference WE001186 and WE001187) 0 **Note 2 (Juarez Only): Planners must sign for notification only. REVISION | Change Description | A | Original Issue | | |

1.0 1.0 PURPOSE 2.1 The purpose of this protocol is to establish the elements required for the successful implementation of product complaint analysis and reporting for the following Houdini: 2.2 Packaging Codes 2.3.1 Harmonic ACE Curved Shears with Ergonomic Handle, Hand Control, to include product codes, ACE23E (23cm length) and ACE36E (36cm length). 2.3.2 Torque Wrench 2.0 SCOPE 3.3 This document applies to the product codes identified in Table 1.
Table 1 PRODUCT CODE: | ASSEMBLY DRAWING: | PRODUCT DESCRIPTION: | ACE23E | D19191 | 23cm Length Harmonic ACE Curved Shears with Ergonomic Handle, Hand Control and Torque Wrench | ACE36E | D19072 | 36cm Length Harmonic ACE Curved Shears with Ergonomic Handle, Hand Control and Torque Wrench | Torque Wrench | TBD | | 3.0 CRITERIA FOR SUCCESS 4.1 Customer Quality Team will have successfully performed analysis on the returned product complaint instruments per section 7.2 and properly completed all required paperwork and database entry. 4.2.1 No minimum number of devices are required with all returned devices to be analyzed in Albuquerque by Customer Quality team and Albuquerque Quality team. 4.0 REFERENCE DOCUMENTS 4.1 CP0011 - Complaint Investigation Procedure 4.2 WE0735 - Product Complaint Work Instructions for Use of Complaint Database 4.3 CP0016 - Document Storage and Retention Procedure 4.4 WE0173 - Complaint Device Analysis Work Instruction 4.5 PR000601 - Finished Goods, Inspection Specification For The Harmonic Synergy 4.6 SPE000859 - Material Specification For The Harmonic Synergy 4.7 RMD000360 - Application FMEA 4.8 RMD000432 - Design FTA 4.9 RMD000430 - Process FMEA 4.10 MFP000048 – Manufacturing Plan 5.0 EQUIPMENT AND MATERIALS 6.2 Safety Glasses, Nitrile Gloves, Lab coats, Mouth Covers. 6.3 Liquid leach detection 6.0 RESPONSIBILITIES 7.4 Key contact person per location is the Packaging Quality Engineer in Albuquerque and Lead Customer Quality in Juarez. 7.5 Juarez Team Leader Customer Quality: Designate appropriate individual(s) to be responsible for performing product complaint analysis and reporting on the required product code. 7.6 Juarez Team Leader Customer Quality: Responsible for required training documentation. 7.7 Houdini Packaging Engineer: Provide design and function training. 7.8 Houdini Packaging Engineer:: Provide product complaint analysis training. 7.9 Houdini Packaging Engineer::: Responsible for Protocol origination, coordination, and completion report. 7.10 Regulatory Reporting Specialist will change analysis (and receiving) site from Cincinnati to Juarez in SIEBEL. 7.0 STRATEGIES AND ASSUMPTIONS 8.11 In 2009, there were XX complaints of ACE/Houdini packaging complaints. With the complaint volume at this level, the product complaint analysis training can be performed using device from the following location: 8.12.2 Product complaint analysis will be conducted on field product returns available at the time of training. 8.12.3 In addition, returned devices previously analyzed may be used in the training. 8.12.4 In addition, new devices may also be used in the training. 8.12 Since all the equipment used to analyze the devices is the same as used on other Harmonic devices, the product complaint training on device performance and analysis will be performed in Albuquerque. 8.0 TRAINING 9.13 The Houdini Packaging Engineer will perform training as required to understand failure modes of the Synergy Product line. 9.14 Transfer team will review risk documents found in Section 4. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 9.0 PREREQUISITES 10.15 Designation of appropriate individual(s) for training. 10.16 Review of the stability scorecard in Manufacturing Plan (MFP000048) to ensure complaint analysis is ready for transfer. 10.17.5 The Synergy products have not reached stabilization. The PI portion has been stabile for all of 2008 10.17.6 The target for the Stabilization was 4661 DPMO and the threshold value is 7109 DPMO. Table 1 shows the DPMO for Synergy Product Codes. 10.17.7 If new failure modes (AFC”) are discovered after the transfer and before stabilization is complete, the stabilization team in Cincinnati team will at the request of customer quality will assist in the analysis and development of the new AFC. Month | DPMO | 2008/Jan | 728 | 2008/Feb | 669 | 2008/Mar | 822 | 2008/April | 0 | 2008/May | 3766 | 2008/June | 0 | 2008/July | 1348 | 2008/Aug | 0 | 2008/Sept | 536 | 2008/Oct | 2030 | 2008/Nov | 3795 | 2008/Dec | 1548 | Table 1 10.0 PROCEDURE 11.17 Analyze devices per WE0173 or appropriate procedure. 11.18 Use Appendix A, Analysis Finding Codes (AFC) list, to categorize any top-level failure modes encountered. 11.19 Results will be recorded in the SIEBEL system. Customer Quality Team will perform analysis and results recorded in the SIEBEL system. 11.20 The analysis site will be changed from Cincinnati to Juarez in SIEBEL. 11.0 PRODUCT DISPOSITION 12.21 Instruments will be disposed of per applicable corporate procedures. 12.0 INVENTORY STRATEGY NA 13.0 COMPLETION ACTIVITIES 14.22 Training records will be attached to Completion Report PRC0035769. 14.23 The Synergy Quality Engineer will write the completion report. 14.24 Upon successful completion of this protocol, training of Juarez associates by R&D associates for product complaint analysis of the Synergy products will be complete. 14.25 On going product inquires will be the responsibility of the Customer Quality group in Juarez. 14.0 Appendices 15.26 Appendix A: SNGCB and SNGHK AFC List

Appendix A: SNGCB and SNGHK AFC List Type | Code | Description | AFC | Blade Damage Tip Off | Blade Damage Tip Off | AFC | Conforming | Specific criteria was evaluated and found to be conforming. | AFC | Blade Damaged Cracked Tip | Any damage to the active blade including scratches, cracks, gouges or nicks. | AFC | Blade Makes Excessive Noise | Abnormal noises resonating from the device. | AFC | Blade Cracked At The Pin Hole | The blade extender is cracked at the pin hole | AFC | Carrier Weld Failure | The weld that attaches the carrier to the shroud has failed. | AFC | Carrier Weld Missing | The carrier was not welded to the shroud. | AFC | Reprocessed | Reprocessed device was returned for analysis. | AFC | Rotation Connector Out Of Track | The rotation connector is not in the shroud track. | AFC | Shroud Weld Failure | The shroud welds have failed. | AFC | Wave Spring Not Seated | The friction button is not able to be pushed. | AFC | Damaged Or Missing Pogo Pins | The pogo pin(s) are either damaged or missing. | AFC | Wire Caught In Track | The activation wire is kinked and caught in the rotation connector / upper shroud track. This makes translating the sheath to its longest position difficult. | AFC | Threaded Stud Broke Off In Instrument | The threaded stud of hand piece broke off inside the shaft. | AFC | Hand Control Button Non Functional | The device cannot be activated or produces intermittent activation via hand control button. | AFC | Blade Damaged | Any damage to the active blade including scratches, cracks, gouges, or nicks | AFC | Blade Tip Off No Visible Damage | Broken blade with no visible damage seen on the remaining active blade in the form of scratches, gouges, or nicks | AFC | Torque Wrench Assembled On Device Backwards | The torque wrench is assembled on the device backwards. The torque wrench becomes stuck after being forced on and is not easily removed | AFC | Thermal Damage Due To Poor Acoustical Coupling | Sheath, shrouds, wires or other components near the acoustic coupling have been damaged by heat created at the acoustical coupling between the blade and hand piece |

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