1100 028 Returned Goods Management Redlines

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 Spacelabs Healthcare                                                                       NUMBER             1100-028         REV             BC


 Global Procedure                                                                           PAGE      1             OF                  3

 FUNCTIONAL OWNER               MANUFACTURING AND OPERATIONS

 SUBJECT                        RETURNED GOODS MANAGEMENT




1.0       Purpose

          This procedure identifies the flow of returned goods within Spacelabs Healthcare by establishing a framework
          for material flow and ownership of required activities. These activities ensure control of returned material,
          ensures that the material is properly tracked, and ensures that the material reaches its intended destination.

2.0       Value Statement

          These activities ensure control of returned material identification, quarantine, disposition, and trackingThis
          procedure provides clear identification of the flow of returned goods to Spacelabs Healthcare.

3.0       Scope

          3.1       This procedure applies to all Spacelabs Healthcare business areas that manage returned goods and
                    associated activities. This includes, but is not limited to:

                    3.1.1     Receiving

                    3.1.2     Quality Management System (QMS) Complaints

                    3.1.3     Demonstration Equipment

                    3.1.4     Refurbished Equipment

                    3.1.5     Customer-owned Equipment

                    3.1.6     Return to Stock Equipment

                    3.1.7     Original Equipment Manufacturer (OEM) Equipment

                    3.1.8     Serviced Equipment

                    3.1.9     Reworked Equipment

          3.2       Applicable standards and regulations:

                        FDA Quality System Regulation (QSR), 21 CFR Part 820
                        Quality Management Systems (QMS), ISO 13485:2003
                        Canadian Medical Devices Regulation (CMDR), SOR 98-282
                        Medical Device Directive (MDD), 93/42/EEC
                        SFDA Quality System Regulation 国食药监械[2009]833号




This document contains proprietary trade secret and confidential information which is the property of Spacelabs Healthcare. This document
and the information it contains are not to be copied, distributed, disclosed to others, or used in any manner outside of Spacelabs Healthcare
without the prior written approval of Spacelabs Healthcare.
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 SUBJECT: RETURNED GOODS MANAGEMENT                                     NUMBER        1100-028      REV            PAGE         2
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4.0     Responsibility

        4.1       The Vice President of Worldwide Manufacturing is responsible for the overall implementation of this
                  procedure, and to ensure a suitable work environment is provided to perform all business and production
                  operations.
                                                                                                                                       Formatted: Bullets and Numbering
        4.2FUNCTIONAL MANAGERS are responsible to ensure:

                  4.2.1Compliance with this procedure

                  4.2.2Established standards are maintained

                  4.2.3Processes and production controls are properly implemented

                  4.2.4Personnel are properly trained

                  4.2.5Processes are followed

5.0     Definitions
                                                                                                                                       Formatted: Bullets and Numbering
        5.1       Return Material Authorization – Number assigned to a customer by Spacelabs, for tracking purposes,
                  authorizing shipment of a customer returned good.

        5.2       Disposition – Instructions dDeterminationing on how a returned good will be processed upon receipt
                  based on known facts of the nature of the return and subsequent action to be commenced.

        5.3       QMS Complaint - any written, electronic, or oral communication that alleges deficiencies related to the
                  identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released
                  for distribution. Note that routine service requests for maintenance, calibration, adjustment, damage
                  repair, use beyond the life of the device, or accident are not considered complaints.                                Formatted: Not Small caps

        5.1FUNCTIONAL MANAGERS – Responsible Ones or Responsible Owners

        5.2PROCESS – A set of interrelated or interacting activities which transforms inputs into outputs.

        5.3PROCESS CONTROLS – The due diligence associated with a specific process.

        5.4WORK ENVIRONMENT – A set of conditions under which work is performed

6.0     RequirementsProcedure
                                                                                                                                       Formatted: Font: Not Bold
        6.1       All product returns require a Return Material Authorization as specified in 051-0022-12
                                                                                                                                       Formatted: Bullets and Numbering
        6.1Attachment 9.1 on the next page identifies the logical progression of material through the Spacelabs PROCESS.               Formatted: Font: Not Italic
                                                                                                                                       Formatted: Font: Not Bold
        6.2The flowchart identifies ownership of parts of the PROCESS and also identifies the associated work instructions
                to be used for further movement of material.
                                                                                                                                       Formatted: Font: Not Bold, Not Italic
        6.2       Designated holding/storage areas must maintain storage controls as specified in 057-0040-00, Handling,
                  Storage, Packaging, and Delivery.

        6.3       Returned products will be identified to ensure traceability to the customer name or account number, RA
                  number, or QMS Complaint number, as applicable during all returned product processing and handling.                  Formatted: Font: Not Bold, Not Italic

        6.4       All returned products will be appropriately dispositioned and material transacted to the identified inventory
 Spacelabs Healthcare                                              Global Procedure
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 SUBJECT: RETURNED GOODS MANAGEMENT                                        NUMBER        1100-028       REV            PAGE           3
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                     location for processing based on the following disposition criteria:
                                                                                                                                          Formatted Table
          Disposition                                                       Criteria

       New Condition        Product will meet all functional and cosmetic requirements and specifications for a new item and
                            product meets cosmetic standards per 062-0194-00

       Loaner               Product will meet all functional and performance requirements and will be brought up to the latest
                            mandatory revision. Cosmetic defects that do not affect the functionality or performance of the product
                            are acceptable.

       Refurbished          Product will meet all functional and performance requirements and will be brought up to the latest
                            mandatory revision and product meets cosmetic standards per 062-0194-00

       Demo                 Product will meet all functional and performance requirements and will be brought up to the latest
                            mandatory revision. Cosmetic defects that do not affect the functionality or performance of the product
                            are acceptable.

       Scrap                Product fails to meet functional and performance requirements and/or cosmetic requirements.

       5 year Quarantine    QMS complaint returned product associated with a report of patient/user injury/incident that has been
                            verified as a product malfunction.

                                                                                                                                          Formatted: Indent: Left: 1", No bullets or
                                                                                                                                          numbering



                                                                                                                                          Formatted: Bullets and Numbering
           6.3No deviations from the PROCESS shown in the flowchart will be accepted as each step plays a critical role in
                  the cost effective cycle of material from receipt to final disposition and future use.

7.0        Training Requirements

           All employees in Order Fulfillment, Equipment Service Center, and Operations and Manufacturing who handle or
           process returned goods will receive initial training on this process and will receive recurring training if the process
           changes. Refer to 1100-017, Training.

8.0        Metrics

           8.1       Metrics are identified in the supporting work instructions as applicable.

9.0        Attachments

           9.1       Returned Goods Management Flowchart

10.0       References

           10.1      Global Procedure 1100-017, Training
                                                                                                                                          Formatted: Bullets and Numbering
           10.2Work Instructions 057-0075-00, QMS Nonconforming Material Process

           10.3Work Instructions 057-0065-00, Refurbishment Operating Guidelines

           10.410.2          Work Instructions 057-010642-00, Receiving, and Receiving Inspection
                                                                                                                                          Formatted: Font: Not Italic
           10.510.3          Work Instructions 057-0025-00, QMS Complaint Product Returns Handling Process


 Spacelabs Healthcare                                                 Global Procedure
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SUBJECT: RETURNED GOODS MANAGEMENT                                NUMBER        1100-028   REV       PAGE   4
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                                                                                                                Formatted: Font: Not Italic
       10.610.4          Work Instructions 057-0023-00, Complaint Evaluation and Investigation

       10.710.5          Work Instructions 051-0028-00, ESC Operations
                                                                                                                Formatted: Font: Not Italic
       10.810.6          Work instructions 051-0030-00, ESC Receiving
                                                                                                                Formatted: Font: Not Italic
       10.7       Work Instructions, 0517-0064-00, Returned Goods Process, Order Fulfillment                    Formatted: Font: Not Italic
                                                                                                                Formatted: Font: Not Italic
       10.8      Work Instructions, 051-0022-12, Return Material Authorization Process
                                                                                                                Formatted: Font: Not Italic
       10.9Work instructions 051-0031-00, ESC Loaner process                                                    Formatted: Font: Not Italic
                                                                                                                Formatted: Font: Not Italic
                                                                                                                Formatted: Font: Not Italic
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                                                                                                                Formatted: Justified

                                                                                                                Formatted: Centered




Spacelabs Healthcare                                         Global Procedure
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SUBJECT: RETURNED GOODS MANAGEMENT                     NUMBER          1100-028    REV                    PAGE        5
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                        Attachment 9.1: Returned Goods Management Flowchart




           RETURN             RECEIVING                EVALUATE /                         DISPOSITION
        AUTHORIZATION          INTAKE                   ASSESS


                                                                                                             MATERIAL
                                                                                                           TRANSACTION
                                                        COMPLAINT                                    NO   FOR MOVEMENT
                              DISTRIBUTION              EVALUATION                   OEM                        TO
                              & MFG – REC               AND INVEST.                                       DISPOSITIONED
                                  DEPT.                  PROCESS                                            INVENTORY
                               057-0106-00               057-0023-00                      YES                LOCATION
           RETURN
          MATERIAL
        AUTHORIZATION
          PROCESS –                 QMS                 EQUIPMENT
          DOMESTIC                                                                   NMR
                                COMPLAINT                SERVICE
                                                                                   PROCESS
           RETURNS               PRODUCT                  CENTER
                               RETURNS AND              OPERATIONS
          051-0022-12            HANDLING
                                                         051-0028-00               057-0075-00
                                  PROCESS

                               057-0025-00




                               EQUIPMENT                                          EQUIPMENT
           RETURN               SERVICE                                            SERVICE
          MATERIAL              CENTER                                              CENTER
                               RECEIVING                                          OPERATIONS
        AUTHORIZATION
        PROCESS – NON          051-0030-00                                         051-0028-00
          DOMESTIC
           RETURNS
                                                                                     MATERIAL
                                                                                   TRANSACTION
                               RETURNED
                                                                                  FOR MOVEMENT
                                GOODS
                                                                                        TO
                               PROCESS
                                                                                  DISPOSITIONED
                                                                                    INVENTORY
                               051-0064-00                                           LOCATION




Spacelabs Healthcare                              Global Procedure
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SUBJECT: RETURNED GOODS MANAGEMENT                        NUMBER     1100-028     REV              PAGE   6
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                                       Return Material
                                        Authorization
                                        051-0022-12




                                        RECEIVING
                                        057-0106-00




                                     Capital Equipment,
                                     Exchanges, Spares,                         QMS Complaint
                  EQUIPMENT
                                      and Accessories                              Returns
                SERVICE CENTER
                                        051-0064-00                              057-0025-00
                   Receiving
                  051-0030-00


                                                                                    QMS
                                                                                 COMPLAINT
                                                                                  Evaluation
                  EQUIPMENT                                                      057-0023-00
                SERVICE CENTER
                   Operations
                  051-0028-00

                                                                                  QMS NMR
                                                                                   Process
                                                                                   057-0075




Spacelabs Healthcare                              Global Procedure

				
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