Professional Documents
Culture Documents
Manufacturing Goods Control Assurance
Manufacturing Goods Control Assurance
Agenda
Administration
Course Objectives
Process Overview Manufacturing Goods
Control Assurance
Topic 1 Manufacturing Inspection Lot
Management
Topic 2 Management of Samples
Topic 3 Results Management
Agenda
(Continued)
Administration
Course Timings
Breaks
Health and Safety
Mobile Phones
Normal UD
Forced UD
Conditional UD
Reassign UD
Rework UD
Blocked UD
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7
Terminology
Term
Definition
Outgoing CofA
Outgoing Certificate of
Analysis
Inspection Plan
Master Inspection
Characteristics (MIC)
A master inspection
characteristic 8describes
Terminology
(Continued)
Term
Sample Drawing Procedure
Sampling Procedure
Definition
A master data object in
Quality Management sample
management that contains
instructions for a physical
sample drawing. It defines
the categories of sample and
the number of samples.
A sampling procedure
defines the rules that
specify how the system
calculates the sample
quantity
Sampling Scheme
Digital Signature
Electronic signature to
identify the user who
performed a specific
9
activity like result
recording
or closure of Quality
Terminology
Term
(Continued)
Definition
Notification
An object to record
information and manage
tasks e.g. Deviation
LI
Laboratory Investigation
Deviation Notification Type
Usage Decision
UN Stock
Unrestricted use
BLK Stock
QI Stock
RF
Radio Frequency
HU
Handling Unit
10
Terminology
(Continued)
Term
Definition
Primary Sample
Pooled Sample
Physical samples to be
created by mixing the
contents of two or more
primary samples from the
same material or batch
Reserve/Retained Sample
BI
Terminology
Term
(Continued)
Definition
MCOM
Manufacturing Confirmation
BIMP
Batch Implicated
Process Order
12
PROCESS OVERVIEW
MANUFACTURING GOODS
CONTROL ASSURANCE
13
Vendor
Re
lea
se
Process
Order
14
15
Key Benefits
Initiation of
Production
Post to QI
Stock
Make Usage
Decision for
Manufacturing
IL (QA11/QA12)
Batch
Manufactured
Inspecti
on
Require
d ?
Yes
Early
Inspection Lot
Created
No
Inspecti
on Lot
Exists ?
Yes
No
No
Post to
Unrestricted
Stock
Any Test
Failed
?
Yes
Management of
Samples
Sample
s
Require
d
?
No
Yes
Management of
Samples
Deviation
Management
TOPIC 1
MANUFACTURING
INSPECTION LOT
MANAGEMENT
18
Initiation of
Production
Post to QI
Stock
Make Usage
Decision for
Manufacturing
IL
(QA11/QA12)
Batch
Manufactured
Inspecti
on
Require
d ?
Yes
Early
Inspection Lot
Created
No
Inspecti
on Lot
Exists ?
Yes
No
No
Post to
Unrestricted
Stock
Any Test
Failed
?
Yes
Management of
Samples
Sample
s
Require
d
?
No
Yes
Management of
Samples
Deviation
Management
20
Inspection lot
21
Handling Unit
A handling unit is a physical unit
consisting of packaging materials (load
carriers/packing material) and the goods
contained on/in it
Goods
Pallet
(Material- Batch)
Packaging
Material
HU Unique
Identification
22
lea
Re
Process
Order
se
Automatic
Creation of
Test/Physical
Samples
No
Automatic
Creation of Early
Inspection Lot 04 Type
Insp.
Not
Require
d/ Autopass?
Yes
No Inspection
Lot Created
Goods
Receipt
Stock Posting
to QI Stock
(Inspection
Lot)
Yes
IL
Exists
?
No
23
Stock Posting
to
(Unrestricted)
Batch
Expiry
Date
Batch Mfg.
Date
25
Inspection Plan
Header Level
Operations Level
MICs
Inspection Points
Inspection Methods
Sampling Procedures
Workcenter
26
27
IL Creation
& Results
Recording
Related
IL UD &
Stock
Posting
Related
28
IL
User
status
29
30
TOPIC 2
MANAGEMENT OF
SAMPLES
31
Management of Samples
Goods Receipt
& Storage
Initiation of
Production
Post to QI
Stock
Make Usage
Decision for
Manufacturing
IL
(QA11/QA12)
Batch
Manufactured
Inspecti
on
Require
d ?
Yes
Early
Inspection Lot
Created
No
Inspecti
on Lot
Exists ?
Yes
No
No
Post to
Unrestricted
Stock
Any Test
Failed
?
Yes
Management of
Samples
Sample
s
Require
d
?
No
Yes
Management of
Samples
Deviation
Management
Sample
Require
d
?
No
Samples
calculation for IL
(Automatic)
Draw Samples
Yes Manually
E.g. Retention
Samples
(QPR1/QPR2)
Incoming
Samples Label
Printing
(Automatic)
Collect Sample
Send Samples to
Lab
No
Confirm Receipt
of Samples at
Lab
(QPR2/QPR7/
YQM_ SAMPLIFE )
Sample
Management
Prima
ry
Poole
d
Reser
ve
34
35
36
NO
YES
37
Creation
38
1 Day
Order End
Date
5th Jan13
1 Day
1 Day
Inspection
Lot Start
Date
3th Jan13
1 Day
Inspection
Lot End
Date
5th Jan13
Order Start
Date
1st Jan13
1 Day
n Date
2nd
Jan13
1 Day
Inspection
Lot Start
Date
2th Jan13
1 Day
Process
Order End
Date
5th Jan13
1 Day
Inspection
Lot End
Date
4th Jan13
43
TOPIC 3
RESULTS MANAGEMENT
44
Results Management
Goods Receipt
& Storage
Initiation of
Production
Post to QI
Stock
Make Usage
Decision for
Manufacturing
IL
(QA11/QA12)
Batch
Manufactured
Inspecti
on
Require
d ?
Yes
Early
Inspection Lot
Created
No
Inspecti
on Lot
Exists ?
Yes
No
No
Post to
Unrestricted
Stock
Any Test
Failed
?
Yes
Management of
Samples
Sample
s
Require
d
?
No
Yes
Management of
Samples
Deviation
Management
Results
Inspection Method
Results
Recording Form
46
47
Test 1 : pH
Test 2:
Moisture
Test 3: Assay
Record
Results Data
for each
Test/MIC
Verify &
Close Results
for each
Test/MIC
Test 4:
Appearance
Inspection Plan
48
Test 1: pH
Test 2:
Moisture
Test 3: Assay
Test 4:
Appearance
Inspection plan
Test: Alcohol
%
Test: Sulphur
%
Additional Tests
E.g. IPC,
Investigational
Sample Tests
49
Results
Recording
Analyst
Results
Verification
Analyst
50
Test Results
Processing
status Before
Test Results
Processing
status After
Results
Recording
Verify &
Close Results
51
Material
Auth.
Group
Intermedia
tes
Z00002
Intermedia
tes
Z00005
Finished
Goods
Z00003
Finished
Goods
Z00006
Recording
ent
Verificatio
n
52
Not Calibrated
Calibrated
53
54
55
56
TOPIC 4
DEFECT MANAGEMENT
57
Defect Management
Goods Receipt
& Storage
Initiation of
Production
Post to QI
Stock
Make Usage
Decision for
Manufacturing
IL
(QA11/QA12)
Batch
Manufactured
Inspecti
on
Require
d ?
Yes
Early
Inspection Lot
Created
No
Inspecti
on Lot
Exists ?
Yes
No
No
Post to
Unrestricted
Stock
Any Test
Failed
?
Yes
Management of
Samples
Sample
s
Require
d
?
No
Yes
Management of
Samples
Deviation
Management
Automatic
Automatic Creation of LI
Deviation Notification for Failed
Tests
59
Laboratory Investigation(LI)
Deviation Notification
Ability to change/display LI Deviation
Notification via ECC/SAP Quality
Management Portal
Standard Priorities driving standard
mandated tasks, with a lead-time of 25
days
Automatic release of approval tasks
Multiple batches, same material, can be
implicated in a single LI Deviation
Notification
60
61
62
Test 1 : pH
Test 2:
Moisture
LI Notification
Item Level
Test 3: Assay
Heade
r
Task
s
Test 4:
Appearance
63
Test 1 : pH
Test 2:
Moisture
Test 3: Assay
Test 4:
Appearance
Defect
1
Defect
2
64
Test 1 : pH
Test 2:
Moisture
Test 3: Assay
Test 4:
Appearance
Defect
1
Defect
2
Defect
3
65
LI Deviation Notification
Priorities
Standard
Mandatory Critical Major
Minor
Tasks
For
Info.
Only
Initial Approval
External Authority
Notification
Remedial Actions
Initial Investigation
Detailed Information
Gathering
Gap Analysis
66
Standard Mandatory
Tasks
Critical Major
Minor
Deviati Deviati Deviati
on/Inci
on
on
dent
For
Info.
Only
TOPIC 5
BATCH PRE RELEASE
CHECKS
68
Initiation of
Production
Post to QI
Stock
Make Usage
Decision for
Manufacturing
IL
(QA11/QA12)
Batch
Manufactured
Inspecti
on
Require
d ?
Yes
Early
Inspection Lot
Created
No
Inspecti
on Lot
Exists ?
Yes
No
No
Post to
Unrestricted
Stock
Any Test
Failed
?
Yes
Management of
Samples
Sample
s
Require
d
?
No
Yes
Management of
Samples
Deviation
Management
70
15 Compliance checks
Apply across the genealogy of the material
SAP set Inspection Lot User Status
automatically as per result of compliance
checks
Restrict selection of UD codes as per ILs
User Status
71
Compliance Checks
Compliance Checks
(Continued)
Compliance Checks
(Continued)
Compliance Checks
(Continued)
76
IL
User
status
77
Forced UD Required
79
Forced UD Required
80
Conditional UD Possible
81
Normal UD Possible
82
83
TOPIC 6
INTRODUCTION TO
MANUFACTURING USAGE
DECISIONS
84
85
Forced UD
Reassign/Cond.UD
Rework UD
80
70
core
S
y
t
i
l
Qua
Blocked UD
86
Unrestricte
d Use Stock
Batch
Status
Unrestricte
d
Restrict
Returns
Stock
Blocked
Stock
87
Stock
Types
Unrestricted
QI Stock
Unrestricted
Blocked Stock
Unrestricted
Unrestricted
Stock
Stock
Availability
for Routine
Use
88
Stock
Types
Restricted
QI Stock
Restricted
Blocked Stock
Restricted
Unrestricted
Stock
Stock
Availability
for Routine
Use
89
AUTOMATIC USAGE
DECISION
90
TOPIC 7
CREATE AND MANAGE
MISCELLANEOUS INSPECTION LOT
91
Make Usage
Decision for
Misc. IL
(QA11/QA12)
Generate and
Apply Labels
(YLB1/YLB2)
Confirm Receipt
of Samples
(QPR2/QPR7/
YQM_ SAMPLIFE )
Pre Release
Compliance
Checks
(YQM_UDREP)
Record Results
(QE51N)
Automatic
93
94
Ap
ply
L
ab
e
Co ls on
nta
ine Sam
rs
p
le
95
96
97
MIC1:
Viscosity
MIC2: pH
Value
MIC3: Colour
MIC4:
Moisture
Inspection plan
98
MIC1:
Viscosity
MIC2: pH
Value
MIC: Alcohol
%
MIC3: Colour
MIC: Sulphur
%
MIC4:
Moisture
Additional Tests
Inspection plan
99
100
101
SUMMARY
102
Normal UD
Forced UD
Conditional UD
Reassign UD
Rework UD
Blocked UD
104
Any questions
105
Assessment
To be taken in myLearning
106
Course
Evaluation
To be taken in myLearning
107
Business
Processes
SOP
Nr.
SOP Title
(CDMS)
SOP_xxxxxxxxxx
xxxxx
TBC
SOP_xxxxxxxxxx
xxxxx
TBC
SOP_xxxxxxxxxx
xxxxx
TBC
SOP_xxxxxxxxxx
xxxxx
TBC
SOP_xxxxxxxxxx
xxxxx
TBC
SOP_xxxxxxxxxx
xxxxx
TBC
SOP_xxxxxxxxxx
xxxxx
TBC
108
109