{"text_format":"3","workbook":"xlsx","n_sheets":9,"sheets":["Listes","Lisez-moi","Exigences","RACI","Plan de contrôle","Risques & Actions","Checklists","Audits & Revues","Dashboard"],"not_rendered":{"charts":1,"defined_names":4},"read":"whole","date_system":"1900"}

{"sheet":"Listes","index":0,"n_rows":5,"n_cols":4,"rows_kept":5}
["Statuts","Criticités","Oui/Non","Résultat Test"]
["Non démarré","Faible","Oui","Succès"]
["En cours","Moyen","Non","Échec"]
["Terminé","Élevé",null,"Bloqué"]
["Bloqué","Critique"]

{"sheet":"Lisez-moi","index":1,"n_rows":10,"n_cols":1,"rows_kept":10,"merged":[[0,0,0,6],[1,0,1,6]]}
["Guide d'utilisation"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["• Remplissez les tables (Exigences, RACI, Plan de contrôle, Risques & Actions, Checklists, Audits)."]
["• Utilisez les menus déroulants (Statut, Criticité, Oui/Non, Résultat Test)."]
["• Couleurs automatiques (RAG). Pas de macros."]
["• KPI & Dashboard se mettent à jour tout seuls."]
["• Ajoutez des lignes jusqu'à 500."]
["• Idée : intégrer PAQ avec traçabilité design."]
["• KPI Pharma : % V&V, CAPA clôturées, NC/Audit."]

{"sheet":"Exigences","index":2,"n_rows":8,"n_cols":9,"rows_kept":8,"merged":[[0,0,0,6],[1,0,1,6]]}
["Plan Qualité Projet — Exigences"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["ID","Exigence","Source","Responsable","Échéance","Statut","Preuve","Commentaire","% Exigences terminées"]
["REQ-001","Conformité exigences client","Client","Chef Qualité","2025-09-21","En cours",null,null,{"$f":"IFERROR(COUNTIF(F5:F500,\"Terminé\")/COUNTA(F5:F500),0)","v":{"v":0,"d":"0.0%"}}]
["REQ-002","Respect normes ISO","Norme","Resp. Qualité Projet","2025-10-06","Non démarré"]
["REQ-003","Dossier V&V complet","Interne","Ing. Validation","2025-10-21","Bloqué"]
["REQ-004","Traçabilité documentaire","Interne","PMO","2025-09-11","Terminé","Lien SharePoint"]

{"sheet":"RACI","index":3,"n_rows":7,"n_cols":6,"rows_kept":7,"merged":[[0,0,0,6],[1,0,1,6]]}
["Matrice RACI"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["Activité","R","A","C","I","Statut"]
["Planification qualité","Resp. Qualité","Chef de Projet","Ing. Process","Direction","En cours"]
["Revue conception","Ing. Conception","Chef de Projet","Qualité","Client","Non démarré"]
["Qualification/Validation","Ing. Validation","Qualité","Production","Direction","Bloqué"]

{"sheet":"Plan de contrôle","index":4,"n_rows":7,"n_cols":11,"rows_kept":7,"merged":[[0,0,0,6],[1,0,1,6]]}
["Plan de Contrôle / PAQ"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["Phase/Processus","Contrôle","Méthode","Fréquence","Échantillon","Critère d'acceptation","Responsable","Preuve","Statut",null,"% Contrôles actifs"]
["Réception","Contrôle matières (certificat GMP)","Vérif. COA/DMF","Chaque lot","100%","COA conforme","QA",null,"En cours",null,{"$f":"IFERROR(COUNTIF(I5:I500,\"En cours\")+COUNTIF(I5:I500,\"Terminé\"),0)/MAX(COUNTA(I5:I500),1)","v":{"v":0,"d":"0.0%"}}]
["Process","Contrôle en cours (IPC)","Procédure IPC-07","Toutes 2h","AQL 0.65","Paramètres OK","Production",null,"Non démarré"]
["Libération","Dossier de lot (DHR)","Rev. DHR","Chaque lot","100%","Aucune NC critique","QA",null,"Bloqué"]

{"sheet":"Risques & Actions","index":5,"n_rows":7,"n_cols":11,"rows_kept":7,"merged":[[0,0,0,6],[1,0,1,6]]}
["Risques & Actions Qualité"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["Risque","Cause","Effet","Criticité","Mesure/Action","Propriétaire","Échéance","Statut",null,null,"% Actions clôturées"]
["NC récurrentes","Procédure inadaptée","Retards & rebut","Élevé","Réviser procédure","Qualité","2025-09-06","En cours",null,null,{"$f":"IFERROR(COUNTIF(H5:H500,\"Terminé\")/COUNTA(H5:H500),0)","v":{"v":0,"d":"0.0%"}}]
["Fournisseur instable","Variabilité lot","Échec tests","Critique","Audit fournisseur","Achat","2025-09-16","Non démarré"]
["Perte traçabilité","Outillage non ID","Risque rappel","Moyen","Marquage","Production","2025-09-01","Terminé"]

{"sheet":"Checklists","index":6,"n_rows":7,"n_cols":7,"rows_kept":7,"merged":[[0,0,0,6],[1,0,1,6]]}
["Checklists de Qualité"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["Point de contrôle","Fréquence","Responsable","Preuve","Conforme (Oui/Non)","Observation","Statut"]
["Check 5S zone critique","Quotidien","Superviseur","Photo","Oui",null,"Terminé"]
["Vérif. calibration","Mensuel","Métrologie","Certificat","Non","Étalon en retard","En cours"]
["Archivage CR de revue","Hebdo","PMO","Lien","Oui",null,"Non démarré"]

{"sheet":"Audits & Revues","index":7,"n_rows":7,"n_cols":11,"rows_kept":7,"merged":[[0,0,0,6],[1,0,1,6]]}
["Audits & Revues"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["Type","Date","Auditeur","Périmètre/Zone","NC détectées","Actions ouvertes","Délai moyen clôture (j)","Statut",null,null,"NC / Audit (moyenne)"]
["Audit interne","2025-08-08","Auditeur A","Production",5,2,10,"En cours",null,null,{"$f":"IFERROR(AVERAGE(E5:E500),0)","v":0}]
["Revue de processus","2025-08-15","Chef Qualité","Processus X",0,0,0,"Terminé"]
["Audit fournisseur","2025-07-23","Auditeur B","Fournisseur Y",3,1,15,"Non démarré"]

{"sheet":"Dashboard","index":8,"n_rows":8,"n_cols":5,"rows_kept":8,"merged":[[0,0,0,6],[1,0,1,6]]}
["Tableau de Bord Qualité"]
["Situation : Développement d'un dispositif médical classe IIa (ISO 13485, GMP, validations)."]
[]
["KPI","Valeur",null,"Statut","Nb"]
["% Exigences terminées",{"$f":"'Exigences'!I5","v":0},null,"Non démarré",{"$f":"COUNTIF('Exigences'!F5:F500,\"Non démarré\")","v":0}]
["% Actions risques clôturées",{"$f":"'Risques & Actions'!K5","v":0},null,"En cours",{"$f":"COUNTIF('Exigences'!F5:F500,\"En cours\")","v":0}]
["NC / Audit (moy.)",{"$f":"'Audits & Revues'!K5","v":0},null,"Terminé",{"$f":"COUNTIF('Exigences'!F5:F500,\"Terminé\")","v":0}]
[{"$nulls":3},"Bloqué",{"$f":"COUNTIF('Exigences'!F5:F500,\"Bloqué\")","v":0}]