Title Metrics Review Quality Plan Page 1 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 This document is electronically signed in the Xxx-Xxx, Inc. Product Lifecycle Management (PLM) System. Approvals can be obtained from the ccM system which displays the selected approvers, their approval roles, and approval dates. PROPRIETARY AND CONFIDENTIAL DOCUMENT FOR XXX-XXX, INC. USE ONLY. This document is property of Xxx-Xxx and may not be used, reproduced, published or disclosed to others without authorization from Xxx-Xxx. Owner Attachments (Optional): Qty Pages Page Sequencing Title Metrics Review Quality Plan Page 2 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 II. SCOPE PRODUCT LINES AFFECTED) This plan encompasses the initiatives and activities undertaken by Xxx-Xxx (Xxx) to perform a retrospective review of the quality of our products and processes using the compliance lens of today’s Quality Systems. The review will look at product and process activities performed at minimum during the period from (((insert here))) The review activities shall take place during sss to ccc. III. PURPOSE This plan is to describe Xxx-Xxx’s overall approach to define the data to be compiled and reviewed, and the metrics to be applied to the data analysis results with the intent to identify any product issues from the past which may not have been adequately addressed. The results of this activity shall be provided as input to management review. The output of this activity shall be reviewed by including but not limited to: Quality Review Board, Management Review, Statistical Techniques Quality Procedure (QP vvv7000005) and Corrective and Preventive Action System Measures Work Instruction (WI vvv7000006) for potential key management process changes. IIII. JUSTIFICATION This plan has been developed to enable Executive Management at Xxx-Xxx to evaluate the effectiveness of the Quality Systems and Policies. It shall remain in effect until the end of FY10-Q4 and may be extended, terminated, or modified as determined by management with executive responsibility. The start date for the periodicity of this review is in alignment with the implementation of the processes and activities which regulate the Failure Analysis Center. The end date for the periodicity of this review is in alignment with when the activities of this plan began. IV. ACRONYMS AND DEFINITIONS Acronym Name Description QS Document FAC Failure Analysis Center The Team which facilitates the analysis of alleged failed product from the field IQA Incoming Quality The Team which performs acceptance activities of Assurance material used in product manufacturing MDR Medical Device The source of data for critical field events related to Reporting our products MOL Master Observation The source of data for design xxx systems and Log processes CAPA Corrective And The system responsible for monitoring and resolving Preventive Action significant product and process problems. Title Metrics Review Quality Plan Page 3 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 Acronym Name Description QS Document NC Non Conformance The source of data for nonconformance acceptance activities performed by IQA NCR Non Conformance The source of data for a nonconformance of product Record identified during the manufacture processes. NCE Non Conforming The source of data for a nonconformance identified Equipment with the equipment used in the manufacture processes. SCAR Supplier Corrective The source of data for tracking supplier corrective Action Report action activities. QRB Quality Review Board Group of management representatives who meet regularly to review identified problems and make decisions regarding the required actions. RRF Review Request Form Exception record which documents the frequency and severity of identified problems that are used for QRB decisions V. RESPONSIBILITIES. RESPONSIBILITIES VP, Quality – To actively participate as the Xxx-Xxx Management Representative, to provide updates to senior management as required, to provide the final authority and decision on conflicting quality issues should they arise. System / Process Owners – To define the data and metrics within their responsible systems, facilitate the acquisition and analysis of the data, and present the results of the reviews to management. Data Analysts – To extract and format the appropriate data required to perform the review of defined metrics and ensure the data query processes conform to procedures. VI. OVERVIEW. RESPONSIBILITIES The business processes which affect the understanding of the quality and reliability of Xxx products are: Product Design Material Management Product Manufacture Service and Repair Complaint Handling The business processes which affect the understanding of processes related to regulatory compliance are: Product Design Supplier Management Material Management Product Manufacture Title Metrics Review Quality Plan Page 4 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 Distribution and Tracking Service and Repair Complaint Handling CAPA Corrections and Removals Audits Following are two diagrams which represent an overview of the interaction of Xxx’s business processes, the data they provide, and the monitoring activities in place to ensure quality products and regulatory compliance. Title Metrics Review Quality Plan Page 5 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 Business Processes Design Receive Product Mfg Product Pruduct Product Support Knowledge Data MFG/Pro Pilgrim NCR/ NCs NCE Complaints & MDRs Supplier CARs Service Repair MOL & Failure CAPA Analysis Audits Field Audits Action Understanding Product/Process Quality Data Analysis and Product/Process Measures RRF/QRB Investigate, Correct & Prevent Problems Field MOLs CAPA Actions Title Metrics Review Quality Plan Page 6 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 Knowledge Data Data Analysis and Measures Defined Data Data Report Measures Acquisition Analysis Generation (Queries) Periodic Review Investigate, Correct & Prevent Problems Title Metrics Review Quality Plan Page 7 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 VII. REVIEW PROCESS RESPONSIBILITIES 1. Define the Metrics - The owners of the systems and processes defined in section IV of this plan are responsible to identify the appropriate metrics and their goals that are necessary to understand the quality and compliance of the products and processes within their ownership. 2. Determine Data Requirements – Using the defined metrics identified by the system and process owners, the Data Analysts and System Owners shall collaborate to identify the appropriate information necessary to determine the level of compliance to the metrics. 3. Collect the Data – The Data Analysts shall extract the required data from their relevant systems as inputs to the analysis process. 4. Analyze the Data – The Data Analysts shall compile and format their respective data sets to create the reports necessary to assess the compliance level to each defined measure. The analysis of data for a given System/Process shall be performed by the System/Process Owners in accordance with 7000005 as compared to the defined metrics. 5. Review the Results - The results of the review activities shall be presented to Executive Management during regular scheduled QRB and quarterly management review. 6. Report the Review Output – The conclusions and required actions determined by Executive management shall be documented in a summary report. Title Metrics Review Quality Plan Page 8 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 VIII. METRICS DEFINED The measures defined in this section are designed to facilitate understanding of the status of product and process quality throughout the business processes related to the design and manufacture of Xxx products. Each measure has a defined intent, source, deliverable, goal, and Owner. The following table contains the metrics that have been defined by the respective system/process owners. Area Measure Desc/Intent Data Source Deliverable Goal Owner Manufacturing Product DPU Mfg Defects per Unit (by Mfg/Pro NCR For Each Product: Drive down NCRs and John Larkin Product) DPU Trend Charts identify quality excursions Top 10 NCR by Component & early Category Root Cause by Operation Service & Product Verified failure rate of Service For Each Product: Product Reliability Goal Kevin Wall, Repair Reliability domestic devices. These Reports Verified Failure Rate Trend Kipp Durbin, rates are compared to the Charts John Parks product reliability goals Top 10 Causes by Component Complaints & Reportable 3 Month average rate by SmartSolve® For Each Product: To provide product teams Kipp Durbin MDRs Event Rate product of reported death, Complaints 3 Month Avg Rate Trend Charts and management with malfunction, or serious system timely and accurate MDR injury information CAPA Corrective Status on the number of SmartSolve® RRF Trend chart by record To continuously lower Kevin Wall Action records on time, overdue, CAPA system status product and process Timeliness and closed CAPA Trend chart by record nonconformance status Special Measures Trend chart by record status Supplier SCAR Evaluate supplier quality SCAR/Pilgrim Top Ten Supplier SCAR’s by To identify pareto driven Colleen Management NCR risk indicators through QMIS System product evaluated supplier Clark review of suppler caused NCRs by product line and corrective/preventive NCRs and SCARs. supplier actions to reduce and eliminate non- conformances. Corrections & Field Actions Trend field actions by Field Actions Trend chart by product line ID root causes of field Todd Bandy Removals product line Trend chart by Root Cause actions for management review FAC Failure Analysis Measure the timeliness of Service Trend chart of average days 14 days John Parks Timeliness the field product failure Reports from device call date to FAC analysis complete date Title Metrics Review Quality Plan Page 9 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 Area Measure Desc/Intent Data Source Deliverable Goal Owner IQA IQA Evaluate overall supplier NC’s/Pilgrim Rolling 12 month trend chart for Identify and develop Jim Jones quality performance QMIS system all product receipts with reject actions to continuously or through review and rate/first pass acceptance of reduce supplier Vicki measure of first pass incoming material lots. rejects/nonconformances. Whittney acceptance rates and Top Ten Suppliers by Reject trends for incoming material Rate lots. Product MOLs MOLS Maren Design Filemaker Pro Nelson DB Audits Repeat audit Number of repeat findings Audits Management Review Audit Zero repeat audit findings Bitewlgn findings during the year conducted per Report Debalkew audit schedule Title Metrics Review Quality Plan Page 10 of 10 Doc Type General Document Record Doc ID 3300357 Doc Rev C Doc State Released State Date 12/18/2008 IX. DATA REQUIREMENTS Data requirements shall adequately and appropriately support the purpose and scope of this plan. X. DATA COLLECTION Data collection shall adequately and appropriately support the purpose and scope of this plan. XI. DATA ANALYSIS Data analysis shall adequately and appropriately support the purpose and scope of this plan. XII. REVIEW & REPORT OUTPUT Data Review and report output shall adequately and appropriately support the purpose and scope of this plan.