21 CFR part 11 retrospective assessment val plan

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					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
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   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.

				
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