Production Management Process

Procédures de production détaillées

Cinq voies contrôlées, de la planification au dépôt

Chaque voie suit sa propre séquence définie par la source. Ouvrez une voie pour consulter les étapes opérationnelles et les éléments probants conservés pour ce travail.

01Recevoir le calendrier PMC
LaneI Processus d’émulsificationPesée des formules et exécution automatisée des processus.
  1. 1 Plan d’émulsification approuvé et mise en circulation de la fiche de procédéPlan & SOP release
    What happens

    Plan d’émulsification approuvé et mise en circulation de la fiche de procédé is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  2. 2 Préparation des matières en entrepôt et sortie par scanMaterial scan-out
    What happens

    Préparation des matières en entrepôt et sortie par scan is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  3. 3 Formation préalable à la production et préparation de la ligneLine readiness
    What happens

    Formation préalable à la production et préparation de la ligne is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  4. 4 Transmission de la formule au système de pesée
    What happens

    Transmission de la formule au système de pesée is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  5. 5 Vérification par scan des matières premières
    What happens

    Vérification par scan des matières premières is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  6. 6 Identification de la pesée
    What happens

    Identification de la pesée is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  7. 7 Sélection de la cuve et du procédé
    What happens

    Sélection de la cuve et du procédé is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  8. 8 Scan pour alimentation
    What happens

    Scan pour alimentation is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  9. 9 Exécution automatisée du procédé
    What happens

    Exécution automatisée du procédé is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  10. 10 Contrôle en cours de procédé
    What happens

    Contrôle en cours de procédé is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  11. 11 Déchargement, pesée et identification par étiquette
    What happens

    Déchargement, pesée et identification par étiquette is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  12. 12 Mise en attente pour inspection
    What happens

    The stated production checkpoint is inspected or formally confirmed.

    What is checked

    The defined condition or acceptance confirmation is reviewed before the route continues.

    What is recorded

    The inspection or confirmation result is retained in the applicable production documentation.

  13. 13 Classement du dossier de lot
    What happens

    Classement du dossier de lot is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

Control & evidence

Plan et fiche de processus approuvés ; sortie de stock par scan ; identification de la formule et de la pesée ; inspection en cours de processus ; registres de déchargement et de lot.

LaneII Prétraitement des matériaux d’emballagePréparation, prétraitement et contrôle de l’emplacement des matériaux d’emballage.
  1. 1 Plan de prétraitement approuvé et publication de la procédure opératoire standardPlan & SOP release
    What happens

    Plan de prétraitement approuvé et publication de la procédure opératoire standard is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  2. 2 Préparation des matériaux et sortie par scan de l’entrepôtMaterial scan-out
    What happens

    Préparation des matériaux et sortie par scan de l’entrepôt is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  3. 3 Formation préalable à la production et préparation de la ligneLine readiness
    What happens

    Formation préalable à la production et préparation de la ligne is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  4. 4 Déballage, mise en correspondance et prétraitement
    What happens

    Déballage, mise en correspondance et prétraitement is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  5. 5 Inspection en cours de production
    What happens

    The stated production checkpoint is inspected or formally confirmed.

    What is checked

    The defined condition or acceptance confirmation is reviewed before the route continues.

    What is recorded

    The inspection or confirmation result is retained in the applicable production documentation.

  6. 6 Identification des étiquettes
    What happens

    Identification des étiquettes is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  7. 7 Stockage à l’emplacement attribué
    What happens

    Stockage à l’emplacement attribué is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  8. 8 Classement des dossiers de lots
    What happens

    Classement des dossiers de lots is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

Control & evidence

Plan/SOP de prétraitement approuvé ; sortie des matériaux ; inspection du processus ; étiquettes, stockage aux emplacements attribués et enregistrements des lots.

LaneIII Processus de remplissage et d’emballageConfirmation de la première pièce grâce au remplissage contrôlé et à la réception des produits finis.
  1. 1 Approbation du plan de remplissage/conditionnement et diffusion des procédures opératoires standardPlan & SOP release
    What happens

    Approbation du plan de remplissage/conditionnement et diffusion des procédures opératoires standard is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  2. 2 Préparation des matériaux en entrepôt et sortie par scanMaterial scan-out
    What happens

    Préparation des matériaux en entrepôt et sortie par scan is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  3. 3 Formation avant production et préparation de la ligneLine readiness
    What happens

    Formation avant production et préparation de la ligne is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  4. 4 Confirmation de la première pièce
    What happens

    The stated production checkpoint is inspected or formally confirmed.

    What is checked

    The defined condition or acceptance confirmation is reviewed before the route continues.

    What is recorded

    The inspection or confirmation result is retained in the applicable production documentation.

  5. 5 Production de remplissage et de conditionnement
    What happens

    Production de remplissage et de conditionnement is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  6. 6 Contrôle en cours de processus
    What happens

    Contrôle en cours de processus is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  7. 7 Contrôle de la ligne de remplissage
    What happens

    Contrôle de la ligne de remplissage is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  8. 8 Identification des étiquettes
    What happens

    Identification des étiquettes is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  9. 9 Réception des produits finis
    What happens

    Réception des produits finis is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  10. 10 Archivage des dossiers de lot
    What happens

    Archivage des dossiers de lot is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

Control & evidence

Plan approuvé/SOP ; sortie de stock des matières ; confirmation de la première pièce ; inspections en cours de processus et sur la ligne de remplissage ; étiquettes, enregistrements des réceptions et des lots.

LaneIV Processus d’assemblageTravail d’assemblage contrôlé, de la confirmation de la première pièce jusqu’à la réception des produits finis.
  1. 1 Approbation du plan d’assemblage et diffusion des procédures opératoires standardPlan & SOP release
    What happens

    Approbation du plan d’assemblage et diffusion des procédures opératoires standard is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  2. 2 Préparation des matériaux et sortie par scan de l’entrepôtMaterial scan-out
    What happens

    Préparation des matériaux et sortie par scan de l’entrepôt is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  3. 3 Formation avant production et préparation de la ligneLine readiness
    What happens

    Formation avant production et préparation de la ligne is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  4. 4 Confirmation de la première pièce
    What happens

    The stated production checkpoint is inspected or formally confirmed.

    What is checked

    The defined condition or acceptance confirmation is reviewed before the route continues.

    What is recorded

    The inspection or confirmation result is retained in the applicable production documentation.

  5. 5 Production d’assemblage
    What happens

    Production d’assemblage is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  6. 6 Inspection en cours de processus
    What happens

    The stated production checkpoint is inspected or formally confirmed.

    What is checked

    The defined condition or acceptance confirmation is reviewed before the route continues.

    What is recorded

    The inspection or confirmation result is retained in the applicable production documentation.

  7. 7 Identification des étiquettes
    What happens

    Identification des étiquettes is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  8. 8 Réception des produits finis
    What happens

    Réception des produits finis is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  9. 9 Classement des dossiers de lot
    What happens

    Classement des dossiers de lot is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

Control & evidence

Plan approuvé/SOP ; sortie de stock des matériaux ; confirmation de la première pièce ; inspection en cours de processus ; étiquettes, entrée des produits finis et dossiers de lot.

LaneV Processus de retour du matérielUne procédure de retour distincte permet d’identifier et de documenter les matériaux inutilisés.
  1. 1 Classification, comptage ou peséePlan & SOP release
    What happens

    Returned material is classified and then counted or weighed.

    What is checked

    The material category and returned quantity are confirmed before identification.

    What is recorded

    The return classification and count or weight is retained in the return documentation.

  2. 2 Identification des étiquettesMaterial scan-out
    What happens

    Identification des étiquettes is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  3. 3 Confirmation de l’inspectionLine readiness
    What happens

    The stated production checkpoint is inspected or formally confirmed.

    What is checked

    The defined condition or acceptance confirmation is reviewed before the route continues.

    What is recorded

    The inspection or confirmation result is retained in the applicable production documentation.

  4. 4 Transfert et remise en stock
    What happens

    Transfert et remise en stock is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

  5. 5 Classement des documents
    What happens

    Classement des documents is carried out as the defined operation in this production lane.

    What is checked

    The released process requirement for this operation is reviewed before the lane proceeds.

    What is recorded

    Completion of this operation is retained in the applicable production or batch record.

Control & evidence

Retour du dossier de classification/comptage ou de pesée ; identification de l’étiquette ; confirmation de l’inspection ; transfert pour remise en stock et documents archivés.

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