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