QS # Description SQE RELATED Acronimo

QS00001 HILL-ROM QUALITY MANUAL Y

QS00131 Supplier Change Request (SCR) Y SCR
QS00077 SUPPLIER CHANGE CONTROL Y
QS02943 Supplier New Part Approval Process Y SNAP
QS02944 SNAP AGREEMENT AND APPROVAL Y SNAP
QS00073 DIRECT MATERIAL SUPPLIER SELECTION AND EVALUATION Y
QS01212 Supplier Add/Change Y
QS00079 Non Disclosure Agreement (NDA) Y NDA

QS00124 Supplier Survey Y

QS12987 SUPPLIER MONITORING Y
QS13001 Supplier Quality Council (SQC) form Y SQC
QS13196 SUPPLIER PERFORMANCE TRENDING
QS13197 Supplier Performance Trending Summary Form
QS00303 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) PROCESS Y SCAR
SCAR Initiation Request in Agile
QS14433 SCAR PROCESS – AGILE WORKFLOW SCAR
QS13221 SCAR Initiation Request Form Y SCAR
QS13222 SCAR Containment Form Y SCAR
QS13223 SCAR Investigation Form Y SCAR
QS12997 Supplier Re-Evaluation Form Y
QS13227 SCAR Verification of Effectiveness Form Y SCAR
QS14432 SCAR Implementation Form SCAR
QS01215 MATERIAL REVIEW BOARD PROCESS
QS01715 Nonconforming Material Identification Tag (NCMIT) NCMIT
QS02191 JDE Processing Nonconforming Production Material N
QS02363 Agile NCMR Creator Work Instruction NCMR
QS02367 AGILE NCMR APPROVER Y NCMR
QS02364 AGILE NCMR CHANGE ANALYST NCMR
QS00088 CONTROL OF NONCONFORMING MATERIAL Y NCMR
QS01222 Concession Y CONC
BS00990 CHANGE NOTICE CREATOR APPROVER AND CHANGE ANALYST ROLES SCN
Supplier change notice SCN
Design History File DHF
Device Master Records DMR
Device History Records DHR
QARA0001 Quality Systems FDA Audit Preparedness Training
BS00318 AGILE APPROVED SUPPLIER LIST

QS01476 NPI BUYOUT PROCESS

APPROVED MANUFACTURERS LIST (AML)
BS00920 APPROVED VENDOR LIST (AVL) OPERATION IN AGILE AML
QS05391 ENTERING 8D’S, SNAP’S AND FAI’S INTO AGILE
QS06179 SERVICE PARTS RELEASE CONTROL FORM
QS00072 ENGINEERING CHANGE/RELEASE PROCESS N
QS01230 PRODUCT ENGINEERING: CONFIGURABLE STANDARD AND SPECIAL
QS00039 DOCUMENT CONTROL Y
QS00128 CORRECTIVE AND PREVENTIVE ACTION Y CAPA
QS06104 Corrective Action Initiation Checklist Y CAPA
QS08907 Corrective Action Investigation Form Y CAPA
QS07000 Corrective Action Request Extension Y CAPA
QS08909 Corrective Action Investigation Tool Workbook Y CAPA
QS08910 Corrective Action Planning Y CAPA
QS08903 CORRECTIVE ACTION CLOSURE REVIEW CHECKLIST Y CAPA
QS08904 Action Plan Review Checklist Y CAPA
QS07024 NONCONFORMANCE EVALUATION FORM - SUPPLIER DEFECT CAPA
QS07025 Nonconformance Evaluation Form – Concession Y CAPA
QS07027 NONCONFORMANCE EVALUATION FORM - DESIGN DEFECT Y CAPA
QS07031 NONCONFORMANCE EVALUATION FORM - TRENDING Y CAPA

QS07035 NONCONFORMANCE EVALUATION FORM - MANUFACTURING DEFECT Y CAPA

QS07044 NONCONFORMANCE EVALUATION FORM - MANAGEMENT REVIEW Y CAPA
QS07071 Nonconformance Evaluation Form – QMS Y CAPA

QS05200 REACH AND ROHS Y

QS00120 FIELD ACTION PROCESS N
QS13504 PROCESS VALIDATION FOR MONTERREY FACILITY N
QS14346 Critical System Change Control N CSC
QS13498 Completion Report N
QS14347 Technical Report N
QS02769 VALIDATION MASTER PLAN N
QS13501 Master Validation Plan form N
QS13500 Installation Qualification N IQ
QS13502 Operational Qualification (OQ) OQ
QS13503 Performance Qualification (PQ) N PQ

QS13937 VENDOR QUALITY NOTICE (VQN) Y VQN

QS13935 Vendor Quality Notice Form Y VQN
QS02162 MONTERREY QUALITY SYSTEM DEFINITION
QS00212 QUALITY PLANNING
QS04020 QUALITY PLANNING TEMPLATE
QS00089 MANAGEMENT REVIEW
QS13653 INSPECCION RECIBO EN JDE incoming
QS00097 COMPLAINT MANAGEMENT Y
QS14238 Complaint Intake Questionnaire N
QS00129 Quality Records Control Y
QS02510 INVESTIGACION Y ANALISIS DE QUEJAS DE CLIENTE
QS01172 MONTERREY SHELF LIFE AND PERISHABILITY AUDIT N incoming
QS13129 Etiqueta de fecha caducidad incoming
QS13693 PROCEDIMIENTO DE CONCESIONES Y
QS13710 Lista de Revision para Justificacion Tecnica
QS13588 SISTEMA DE CONTROL DE DOCUMENTOS MONTERREY Y
QS14516 Formato de Cambio de Documentos CRCO
QS03972 LMS Certification Changes
QS13713 Evaluacion por Actualizacion de Documentos Corporativos
QS01011 MONTERREY-CALIBRACIONES N
Equipo de Inspección, Medición y Prueba EIMP

Sistema de Administración de la Calibracion CMS

QS00873 Etiqueta de calibración
QS02738 INDIRECT SUPPLIER SELECTION AND EVALUATION Y
QS01012 Forma de EIMP fuera de Calibración/Tolerancia
QS00883 Registro de Verificación y/o Ajuste
QS13585 EVALUACIÓN Y CONTROLES AMBIENTALES N
QS13586 Formato de Evaluación de Factores Ambientales N
QS13587 FORMATO PARA MONITOREO AMBIENTAL N
QS00090 QUALITY AUDITS N
QS08902 NON CONFORMANCE EVALUATION FORM - AUDIT FINDINGS Y
QS13294 INTERNAL QUALITY AUDITS MONTERREY Y
QS13296 Plan De Auditoría Interna Y
QS13300 Reporte de Auditoría interna Y
QS13649 No Conformidades de Auditorías Internas y Externas
QS02838 ROLLED THROUGHPUT YIELD (RTY) N
BS01155 PROCESO DE PARO DE LÍNEA Y SOPORTE
BS01154 REGLAS PARA PARO DE LINEA EN ENSAMBLE
QS03004 RECIBO DE EQUIPO NUEVO Y
QS09690 GENERACION DE ÓRDENES DE SERVICIOS DE MANTENIMIENTO
QS04426 Formato de entrenamiento. N

QS14113 CAPA PROCESSING IN AGILE FOR CAPA OWNER N CAPA

QS13230 COMPLAINT MANAGEMENT PROCESS - JDE AND ETQ ETQ
QS00299 ENGINEERING INVESTIGATION N
QS02355 Engineering Investigation Form N
QS11678 RECEIVING INSPECTION WORKBENCH IN JDE Y incoming
QS12067 Hoja de Inspección Forma (Monterrey) incoming
QS00081 ACEPTACION DE MATERIAL - INSPECCION RECIBO Y incoming
QS14177 Receiving Inspection Criteria Change Form Y incoming
QS11697 View/Change Receiving Inspection Frequency and Steps in JDE Y incoming
QS14176 VIEW/CHANGE RECEIVING INSPECTION ROUTING IN JDE Y incoming
QS01216 CONTROL DE MATERIAL NO CONFORME MONTERREY Y No confor
QS13421 Etiqueta RETENIDO Y No confor
QS13515 Etiqueta RECHAZADO Y No confor
QS13534 Reporte de material no conforme (no aplicable a inspeccion recibo) Y No confor
QS13533 Reporte de Material No Conforme Inspección recibo Y No confor
Procesar la disposición regreso a proveedor (RETURN TO VENDOR (RTV));
QS02198 WI Y RTV
QS03002 Formato de re-trabajos N RW
QS13535 Formato de Sorteos Sorteo
Procedimiento de Retenido para productos terminadas “Hold Procedure for
QS01391 Finished goods"; WI
QS08018 Matriz de retención de registros “Records Retention Matrix”;

QS11545 P1440B BASIC CARE BRAZIL INMETRO FINAL INSPECTION PROCEDURE Basic care
QS03555 TECNICAS ESTADISTICAS MONTERREY Y
QS00096 Tendencias de Calidad Y

QS00032 PROCESS VALIDATION

QS00075 SUPPLIER AUDIT PROGRAM Y
QS00126 Audit Report Form
QS00125 Quality system Checklist

QS06702
QS06703
QS06704
QS06705
QS06706
QS06707 Checklists for process audits
QS00127 Sign-in form for opening and closing meetings
QS00080 PURCHASING AND ORDER FULFILLMENT
QS00123 CHARACTERISTICS CLASSIFICATION Y CC
QS00674 PROCESS CAPABILITY ANALYSIS
QS06708 OUTLIER AND NORMALITY ASSESSMENT PROCEDURE
QS00691 DESIGN CONTROL N
REQUIREMENTS FOR PRODUCT LABELS AND LABELING ON THE
QS01281 PRODUCTION FLOOR N
QS02541 Item Restriction from the Supplier Address Book.
NEW OR EXISTING PART FIRST ARTICLE INSPECTION (FAI) GUIDELINE FOR
QS02947 SUPPLIERS FAI
QS02952 First Article Inspection Datasheet FAI
QS03623 SHELF LIFE & PERISHABILITY
QS03624 Shelf Life Perishability Identification Sticker
QS06693 SUPPLIER PRODUCT PERFORMANCE REPORTING
QS06725 MANUFACTURING SAMPLING PLANS
QS06840 SUPPLIER CONTINUOUS IMPROVEMENT GUIDE
QS07048 VERIFICATION/VALIDATION SAMPLING PLANS FOR PERCENT CONFORMING
GUIDELINE FOR SUPPLIER QUALITY MANAGEMENT PLAN AND READINESS
QS07261 CHECKLIST
QS08100 RECORDS MANAGEMENT N
QS08521 NON-CONFORMING MATERIAL PROCESS
QS10412 SUPPLIER CHARGEBACK PROCESS
QS13172 ENGINEERING DESIGN CHANGE PROCESS N SUS / CDP
QS13181 DVM WORKFLOW CHANGE PROCESS N DVM
QS13189 PILOT WORKFLOW CHANGE PROCESS N NDP
QS13337 RECORDS RETENTION SCHEDULE CHANGE REQUEST FORM
QS04371 MONTERREY TENDENCIAS DE CALIDAD Y
QS08204 CONTROL DE MATERIAL N
QS00710 VALIDATION N
QS02448 HILL-ROM NON-PRODUCT SOFTWARE VALIDATION PROCESS N
QS03604 PROCESS VALIDATION PROTOCOL WORK INSTRUCTION
QS09404 TEST SYSTEM SOFTWARE MASTER LIST
QS13180 MODIFIED WORKFLOW CHANGE PROCESS N
QS01927 SUPPLIER QUALITY HANDBOOK Y
QS01075 REGISTRAR CHANGE NOTIFICATIONS N
QS07905 HILL-ROM QUALITY POLICY N
QS02887 CERTIFICADO A LA REVISION GERENCIAL N
QS10486 REVISION DE LA GERENCIA N
QS08901 MANAGEMENT RESPONSABILITY AND DELEGATION DOC N CAB
QS01570 AUDIT MEETING ATTENDANCE RECORD Y
QS01575 INTERNAL AUDIT CLOSURE NOTICE Y
QS13295 INTERNAL QUALITY AUDIT SCHEDULE Y
QS13298 REGISTRO DE ASISTENCIA A REUNION DE AUDITORIA Y
QS14273 VISITOR WELCOME N
QS14271 AUDIT MANAGEMENT AND LOGISTICS N
QS04572 TRAINING N
QS01134 PROCEDIMIENTO DE CAPACITACIÓN MONTERREY N
QS02676 LISTADO DE REQ. DE ENTRENAMIENTOS P/PERSONAL PRODUCTIVO N
QS04425 ASSIGNING AND DOCUMENTS TRAINING N
QS13602 REGISTRO DE ENTRENAMIENTO MONTERREY (LISTA DE ASISTENCIA) N
QS00518 PRODUCT DEVELOPMENT PROCESS FRAMEWORK (PDP) N
QS01641 DESIGN VERIFICATION AND VALIDATION N

QS02696 CAMBIO DE INGENIERIA DONDE HILL-ROM NO ES DUEÑO DEL DISEÑO N

QS04893 DEVICE HISTORY RECORD INDEX P1170 CAREASSIST N
QS06332 TECHNICAL DESIGN REVIEW N
QS03282 COMMERCIAL RELEASE NOTICE FORM N
QS11381 COMMERCIAL RELEASE N
QS07520 DOCUMENT CHANGE REVIEW BOARD Y
QS13435 BUENAS PARCTICAS DE DOCUMENTACION Y
QS09681 INSTRUCCIÓN DE TRABAJO Y AYUDAS VISUALES Y
QS10610 FORMA AYUDA VISUAL Y
QS13654 JOB INSTRUCTION TEMPLATE Y
QS08251 PURCHASING SUPPLIER MANAGEMENT Y
QS00084 MATERIAL HANDLING AND STORAGE N
QS00083 MATERIAL IDENTIFICATION AND TRACEABILITY N
QS13229 SCAR INVESTIGATION TOOLKIT Y
QS02663 PROCEDIMIENTO DE RECIBO DE MATERIALES INDIRECTOS Y
QS02664 LISTADO DE MATERIALES INDIRECTOS QUE AFECTAN LA CALIDAD Y
QS09570 MONTERREY RMA ANALYSIS PROCEDURE Y
QS02192 PROCESSING REWORKI DISPOSITION WITH WO N
QS09692 MANTENIMIENTO DE PLANTA Y EQUIPO N
QS04159 DEVICE MASTER RECORD INDEX TEMPLATE N
QS00375 DESIGN FAILURE MODE AND EFFECTS ANALYSIS (DFMEA) N
QS01453 RISK ASSESSMENT AND CONTROL N

QS00027 INSPECTION MEASURING & TESTING EQUIPMENT CONTROL CALIBRATION N

QS07074 QUALITY DATA TERNDING SUMMARY TEMPLATE N
QS00872 TECHNICAL DOC PROCESS: DOC CREATION AND RELEASE N
QS15407 USER/SERVICE MANUAL CLAIMS REVIEW N
QS06090 ANNUAL RISK MANAGEMENT ASSESSMENT FORM N
QS00119 RISK MANAGEMENT N
QS13813 GLOBAL PRODUCTS HOLD N
QS13814 GLOBAL PRODUCTS HOLD FORM N
QS02895 RISK MANAGEMENT REPORT N
QS00433 PRODUCTION AND PROCESS CONTROL N
QS01370 RISK MANAGEMENT PLAN N
QS02960 STD NUMBERING FORMAT FOR COMPLETE PRODUCT AND SUBASSY N
QS02193 PROCESSING SCRAP DISPOSITIONS N
QS02197 JDE Processing Nonconforming Production Material N
QS02157 BIN TO BIN TRANFERS USING DSI OR JDE N
QS02189 JDE ISSUE MATERIAL TO SIP OR ACCOUNT CODE N
QS02184 ITEM AVAILABILITY Y
QS01247 FORMATO DE RETRABAJO Y
QS01209 EMPAQUE Y DISTRIBUCION DE PRODUCTO TERMINADO N
QS09862 CATALOGO DE CODIGO DE DEFECTOS N
QS00086 FINISHED GOODS PACKING AND DISTRIBUTION N
QS00087 DESTRUCTION OF OBSOLETE MATERIAL N
QS13702 REPORTE DE ASEGURAMIENTO DE CALIDAD N
QS13128 PROCESO PARA MAT CON TIEMPO DE VIDA Y/O CADUCIDAD N
QS00167 AUDITORIAS DE PRODUCTO N
QS03187 HAZARDOUS SITUATION LIST N
QS13728 SOLICITUD DE AUDITORIA DE PRODUCTO N
QS13425 ETIQUETA DE ACEPTADO Y
QS13852 PRODUCT PERFORMANCE REVIEW SUMMARY N
QS07504 AGILE PROCESS FOR NON PRODUCT SOFTWARE VALIDATION N
QS04517 FIELD ACTION LETTER N
QS02489 MONTERREY - IDENTIFICACION DE MUESTRAS /DVM/PILOTO/V&V N
QS09407 HILL ROM NAMING CONVENTION FOR PRODUCT LABELING N
QS13844 PREVENCION DE ESD N
QS14125 FORMATO DE MONITOREO DE PIEZAS PROVEEDOR EXTERNO Y
QS02946 PROCESS FAILURE MODE AND EFFECTS ANALYSIS (PFMEA) Y
QS02951 PFMEA FORMAT Y
QS00163 RECORD RETENTION LABEL N
QS13000 JOB DESCRIPTIONS N
QS00026 ACEPTANCES ACTIVITIES - IN PROCESS AND FINISHED DEVICE N
QS13612 DESCRIPCION DEL PUESTO TEMPLATE N
QS02824 MONTERREY - HOJA VIAJERA LINEAS DE ENSAMBLE N
QS00033 STATISTICAL TECHNIQUE Y
QS08239 ACCEPTANCES ACTIVITIES N
QS02894 RTY DEFECTOS DIARIOS CARE ASSIST N
QS15535 FORMATO DE SORTEO Y
QS00121 FIELD ACTION ASSESSMENT CHECKLIST N
QS00122 FIELD ACTION PLAN FORMAT N
QS07028 NON CONFORMANCE EVALUATION FORM - RETURNED PRODUCT Y
QS07001 CORRECTIVE ACTION BOARD MEETING MINUTES Y
QS08905 NON CONFORMANCE EVALUATION FORM LOG Y
QS14897 ETQ - USER GUIDE N
QS13338 RECORD RETENTION SCHEDULE Y
QS13336 GLOBAL RECORDS AND INFORMATION MANAGEMENT N
BS01875 PROC. DE COMPRA DE MATERIAL Y SERVICIOS INDIRECTOS N
QS00344 LABELING N
QS01344 MANEJO Y RECIBOS DE MATERIAL N
QS03363 TWO LETTER PRODUCT LINE DESIGNATIVE N
QS02194 PROCESSING REWORK DISPOSITION N
QS14731 DOCUMENT CONTROLAGILE DC WORKFLOW CREATOR N
BS01767 BUSINESS SYSTEM TEMPLATE FORM N
QS14733 DOCUMENT CONTROL AGILE DC WORKFLOW APPROVER N
QS00870 USING AGILE FOR PRODUCT DEVELOPMENT ISSUES N
QS15459 SUPPLIER CHANGE REQUEST PROCESS AGILE Y
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 COMMENTS

Forma donde el proveedor comunica algun cambio

Procedimiento para llevar a cabo un cambio de materia prima
Tipo A, B, C & D

Cambiar el status de un proveedor

Upon selection of a potential supplier, where risk of intellectual property sharing may exist, sourcing
Sourcing will obtain a Supplier Survey from potential suppliers, the survey is not required for those suppliers approved prior to
year 2003.

Suplier monitoring

Antes de iniciar el SCAR le preguntan a Daniel?

Obsolete

Se usa para ligar alguna accion del proveedor q implique algun cambio interno!?
Disposiciones del material y aprobaciones requeridas, para el repair se requiere una concesion

Aprobar o rechazar un NCMR en Agile

2.1 This work instruction will be used when managing buyout projects where Hill-Rom will be a distributor, but will not be the
manufacturer of a finished product

Manufacturer part creation

Partes de servicio que solo autoriza

job packet??

Recalls???

validacion

Used to capture the initial containment, correction and evaluation by a supplier for issues that do not warrant a SCAR at the tim
discovery.

ETQ (Excellence through Quality), • Hill-Rom’s electronic complaint handling database.

Ingeniería de calidad de proveedores la creación de nuevos ítems con restricción de tiempo de vida y/o caducidad por medio d
Agile.
6.2 Ingeniería de calidad de proveedores ingresa en JDE el ítem con restricción de tiempo de vida y/o caducidad la bandera de:
“siempre inspeccionar”; de modo que, todos estos ítems sean siempre inspeccionados antes de pasar al almacén.
6.3 Inspección identifica y documenta la caducidad del material:

forma para documentar a que certificacion se incluira un documento nuevo

forma para documentar si impactan los cambios corporativos y proporcionar fecha limite

usado para mantener los registros electrónicos y/o impresos de los equipos controlados para calibración y la historia de los equ

1.1 This document is meant to provide instructions on how to use the Agile workflow to process CAPAs and store CAPA data.

PINS - NOIN, criterios de frecuencia de inspeccion ALWAYS - SKIP LOT

documentar racionales para disminuir o definir requerimientos de insp
como crear procedure cards o cambiar frecuencia en JDE
para cambiar la ruta de inspeccion PINS/NOIN

minitab
analisis de estudio de capacidad
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