Improvements (PDF)

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					                                                 DORSET ORTHOPAEDIC COMPANY LTD
                                                                                                                     Doc Ref: P11
Improvements                                                                                                         Issue No: 4
                                                                                                                     Page No: 1 of 1

Quality Manager approval:                                      Process owner:                                        Position:




                        Performance analysis                                                               KPI’s


  Quality Manager: Monitor the following information to identify any            Managing Director: Agree KPI measures with managers during
             concerns and improvement opportunities                                        monthly management review meetings

            SD 139 Product Returns Log
            Prosthetic, Orthotic and Legal satisfaction                          Managers: Implement plans to achieve KPI, measure outcome
            questionnaires                                                      and report achievements during subsequent monthly management
            SD29 Internal Reject Notes                                                                 review meetings
            SD11A / B Remake Report
            SD01 Audit Report
            SD127 Product Returns Form                                           Managing Director: Review KPI achievements during meeting
                                                                                                  and revise as necessary
     Quality Manager: Discuss performance relating to the above
               during monthly quality review meetings
                                                                                                 Managers: File KPI reports

    Quality Manager: Record findings including resulting actions,
  copy to management and ensure resulting actions are implemented
                                                                                                            Go to
                                                                                                           “KPI’s”
                                                                                                           above
                                    Go to
                                “Performance
                                  analysis”
                                   above




                     Risks and improvements


  All staff: Be alert to situations / working practices that could either

                 Be in breach of ISO 13485 requirements
                 Be in breach of client/partner contract conditions
                 Be in breach of statutory / regulatory requirements
                 Jeopardise client satisfaction
    or
                 Ideas to improve, change or eliminate working
                 practices / documentation

 Note: Concerns / ideas may arise from personal experience as
 well as published articles; discussions with colleagues or feedback
 from clients, suppliers and relevant authorities


     All staff: Record details on an SD66 Improvement / Ideas
            Request Form and submit to Quality Manager


  Quality Manager: Review SD66 Improvement / Ideas Request
  Form and agree what action is required ensuring details logged on
         the Improvements / Ideas Suggestion Register


    Quality Manager: Ensure action is taken and followed up to
  ensure it was effective before closing on the SD66 Improvement /
   Ideas Request Form and updating the Improvements / Ideas
                         Suggestion Register



                                  Go to
                                 “Risks &
                              improvements”
                                  above




                                                                                                             Date issued: 26th August 2008