Tài liệu formulation management ppt

PB-Nr: S07 Formulation Maintenance Issued by Date of release Version Page Ing. Mathe Juli 2001 0 1/4 Process owner: Development departments Process purpose and target: Creation and maintenance of production prescriptions inclusive all necessary specifications Schnittstellen Supplier: Document Process input R04-Delivery Laboratory job Laboratory journal product specifications, raw material selection R05-Production Batch formulation Process parameter, corrections S11-Customer service Complaint acknowledgements of the customer Customer: Document Process output R 02-Auftragsabwicklung Item stock article specifications R 05-Production Prescription (PPS) Prescription R 06-delivery Item stock Article specifications monitoring/characteristic numbers quality Quality: Blockings due to prescription errors incorrect inputs / input prescriptions (samples) Environment: PB-Nr: S07 Formulation Maintenance Issued by Date of release Version Page Ing. Mathe Juli 2001 0 2/4 - Prescription : a 8-digit number indicates and contains all production-relevant data as well as the technical specifications - Articles: a 12-digit number indicates and contains apart from a reference to the prescription specification to the bundle and all sales relevant designations. EAN articles indicate a number with 13 digits. PB-Nr: S07 Formulation Maintenance Flow/process documentation/competence First draft of formulation and article creation Responsibility Documents Check of formulation Color correction Raw material correction Formulation database Article database AS : IT Rest : Development see R 05 AS : IT (Sales) Rest : Indoor sales RS : Production (Development) RS : Production OT : Development PS : Development TX : Production, Development All : Development RS : Raw material OT : OT-Info PS : Test requirements TX : Text AS : Article database M07 - Improvement U01 - Government rules U04 - Customer satisfaction Maintainance of article data AS : IT (Sales, Dev., Prod.) Remarks for production and approval OT : Development TX : Production R04 S 11 Formulation Article data R02 R05 Issued by Date of release Version Page Ing. Mathe Juli 2001 0 3/4 PB-Nr: S07 Formulation Maintenance Issued by Date of release Version Page Ing. Mathe Juli 2001 0 4/4 competence range of a prescription: A prescription consists of the following sections: - product number (no subsequent modification possible) - version number (in the PPS one updates automatically) - product description (OT): This contains the basic description the product and is summarized in the EDV form " OT info. ". - the prescription constituents (R-S) (raw material code and quantity) and if necessary process descriptions within the raw material area of the EDV form. - test predeterminations (HP): These contain all checks the inclusive pre-set values for the internal check of the product. The list takes place in the EDV form " test debit specifications. - additional text (TX): In this text field all further information, those necessarily for a product are summarized. - EDV contractions and date of the last modification. - item stock (AS) with date and EDV contraction of the last modification. The item stock contains the sales relevant data for all sales products. Current prescription maintenance: Due to newer realizations or production or raw material-conditioned shifts the prescription must be constantly adapted. These modifications are evidently, comprehensible within the remaining areas by fixing the date and the contraction in the raw material area by an increase of the version number. Applicable documents - EDV documentation Applicable documents EDV documentation . number with 13 digits. PB-Nr: S07 Formulation Maintenance Flow/process documentation/competence First draft of formulation and article creation Responsibility Documents Check. article creation Responsibility Documents Check of formulation Color correction Raw material correction Formulation database Article database AS : IT Rest