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
NAME: | TBD | EXTENSION: | TBD |
TITLE: | Quality Engineer | SITE: | |
Review & Approval Status (Priority or Normal): | |
| Status |
Approval Due Date: | |
| Due Date |
FUNCTION | NAME (PRINT) ...view middle of the document...
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
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...