عملية إدارة الإنتاج

إجراءات الإنتاج التفصيلية

خمسة مسارات مُتحكم بها من الجدولة حتى الإيداع

يتبع كل مسار تسلسله الخاص المحدد بالمصدر. افتح المسار لمراجعة الخطوات التشغيلية والأدلة المحفوظة لذلك العمل.

01استلام جدول PMC
LaneI عملية الاستحلابوزن التركيبات والتنفيذ الآلي للعمليات.
  1. 1 الموافقة على خطة الاستحلاب وإصدار صحيفة العمليةPlan & SOP release
    What happens

    الموافقة على خطة الاستحلاب وإصدار صحيفة العملية 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 تحضير مواد المستودع والمسح الضوئي للخارجMaterial scan-out
    What happens

    تحضير مواد المستودع والمسح الضوئي للخارج 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 التدريب قبل الإنتاج وتجهيز الخطLine readiness
    What happens

    التدريب قبل الإنتاج وتجهيز الخط 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 إصدار التركيبة لنظام الوزن
    What happens

    إصدار التركيبة لنظام الوزن 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 مراجعة مسح المواد الخام
    What happens

    مراجعة مسح المواد الخام 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 تحديد الوزن
    What happens

    تحديد الوزن 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 اختيار الوعاء والعملية
    What happens

    اختيار الوعاء والعملية 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 المسح الضوئي للتغذية
    What happens

    المسح الضوئي للتغذية 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 التنفيذ الآلي للعملية
    What happens

    التنفيذ الآلي للعملية 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 الفحص أثناء العملية
    What happens

    الفحص أثناء العملية 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 التفريغ والوزن وتحديد الملصق
    What happens

    التفريغ والوزن وتحديد الملصق 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 الاحتجاز للفحص
    What happens

    الاحتجاز للفحص 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.

  13. 13 حفظ سجل الدفعة
    What happens

    حفظ سجل الدفعة 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

الخطة المعتمدة وورقة الإجراءات؛ مسح المستودع؛ تحديد التركيبة/الوزن؛ الفحص أثناء العملية؛ سجلات التفريغ والتشغيلات.

LaneII المعالجة الأولية لمواد التعبئة والتغليفتحضير مواد التعبئة والتغليف ومعالجتها الأولية والتحكم في مواقعها.
  1. 1 خطة ما قبل المعالجة المعتمدة وإصدار إجراءات التشغيل القياسيةPlan & SOP release
    What happens

    خطة ما قبل المعالجة المعتمدة وإصدار إجراءات التشغيل القياسية 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 إعداد مواد المستودع والمسح الضوئيMaterial scan-out
    What happens

    إعداد مواد المستودع والمسح الضوئي 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 تدريب ما قبل الإنتاج وإعداد الخطLine readiness
    What happens

    تدريب ما قبل الإنتاج وإعداد الخط 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 تفريغ ومطابقة وما قبل المعالجة
    What happens

    تفريغ ومطابقة وما قبل المعالجة 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 الفحص أثناء العملية
    What happens

    الفحص أثناء العملية 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 تحديد الملصقات
    What happens

    تحديد الملصقات 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 التخزين في الموقع المخصص
    What happens

    التخزين في الموقع المخصص 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 حفظ سجل الدفعات
    What happens

    حفظ سجل الدفعات 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

خطة المعالجة المسبقة المعتمدة/إجراءات التشغيل القياسية؛ مسح المواد للخارج؛ فحص العملية؛ الملصقات، تخزين المواقع المخصصة وسجلات الدفعات.

LaneIII عملية التعبئة والتغليفتأكيد القطعة الأولى من خلال التعبئة الخاضعة للرقابة والواردات من السلع التامة الصنع.
  1. 1 الموافقة على خطة التعبئة والتغليف وإصدار إجراءات التشغيل الموحدةPlan & SOP release
    What happens

    الموافقة على خطة التعبئة والتغليف وإصدار إجراءات التشغيل الموحدة 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 إعداد مواد المخزن ومسحها ضوئيًاMaterial scan-out
    What happens

    إعداد مواد المخزن ومسحها ضوئيًا 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 التدريب قبل الإنتاج وإعداد خط الإنتاجLine readiness
    What happens

    التدريب قبل الإنتاج وإعداد خط الإنتاج 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 تأكيد العينة الأولى
    What happens

    تأكيد العينة الأولى 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 إنتاج التعبئة والتغليف
    What happens

    إنتاج التعبئة والتغليف 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 الفحص أثناء التشغيل
    What happens

    الفحص أثناء التشغيل 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 فحص خط التعبئة
    What happens

    فحص خط التعبئة 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 تعريف الملصقات
    What happens

    تعريف الملصقات 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 استلام البضائع التامة الصنع
    What happens

    استلام البضائع التامة الصنع 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 حفظ سجل الدفعة
    What happens

    حفظ سجل الدفعة 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

الخطة المعتمدة/إجراءات التشغيل القياسية؛ مسح المواد الخارجة؛ تأكيد القطعة الأولى؛ فحوصات أثناء العملية وخط التعبئة؛ الملصقات، السجلات الواردة وسجلات الدُفعات.

LaneIV عملية التجميعيتم التحكم في أعمال التجميع بدءًا من اعتماد القطعة الأولى وصولاً إلى استلام السلع النهائية.
  1. 1 خطة التجميع المعتمدة وإصدار إجراءات التشغيل القياسيةPlan & SOP release
    What happens

    خطة التجميع المعتمدة وإصدار إجراءات التشغيل القياسية 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 إعداد مواد المستودع والمسح الضوئي للخارجMaterial scan-out
    What happens

    إعداد مواد المستودع والمسح الضوئي للخارج 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 التدريب قبل الإنتاج وإعداد الخطLine readiness
    What happens

    التدريب قبل الإنتاج وإعداد الخط 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 تأكيد القطعة الأولى
    What happens

    تأكيد القطعة الأولى 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 إنتاج التجميع
    What happens

    إنتاج التجميع 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 الفحص أثناء العملية
    What happens

    الفحص أثناء العملية 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 تحديد الملصق
    What happens

    تحديد الملصق 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 استلام البضائع التامة الصنع
    What happens

    استلام البضائع التامة الصنع 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 حفظ سجل الدفعة
    What happens

    حفظ سجل الدفعة 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

خطة/إجراء تشغيل قياسي معتمد؛ مسح المواد خارجًا؛ تأكيد القطعة الأولى؛ فحص أثناء العملية؛ الملصقات، استلام السلع تامة الصنع وسجلات الدفعات.

LaneV عملية إرجاع الموادمسار الإرجاع المنفصل يحافظ على المواد غير المستخدمة محددة وموثقة.
  1. 1 التصنيف أو العد أو الوزنPlan & SOP release
    What happens

    التصنيف أو العد أو الوزن 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 تحديد الملصقاتMaterial scan-out
    What happens

    تحديد الملصقات 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 تأكيد الفحصLine readiness
    What happens

    تأكيد الفحص 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 التسليم والإرجاع إلى المخزون
    What happens

    التسليم والإرجاع إلى المخزون 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 حفظ المستندات
    What happens

    حفظ المستندات 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

إعادة تصنيف/عد أو سجل الوزن؛ تعريف الملصق؛ تأكيد الفحص؛ تسليم الإرجاع إلى المخزون والمستندات المودعة.

أسئلة حول عملية عملكم؟ تحدثوا إلى فريقنا.

اختر أخصائيًا لمناقشة التركيبة أو شكل التعبئة أو ضوابط الإنتاج أو متطلبات الاختبار بمزيد من التفصيل.