Professional Documents
Culture Documents
1 Work flow
2 Transfer master
3 Abstract card associated
4 RM QA Information Sheet (new RM; SS-TDS, SS-SDS & NPS-RMS)
5 RM QA guide
6 In-coming RM accepting specification
7 FBPT discussion form (before trial)
8 Production Work Standard for trial (PWS Scale-up; MO)
9 FBPT review report (after trial; parked into Aichi Database)
10 Field test report
FLOW CHART OF FIRST BATCH PRODUCTION CONTROL
revised on Dec 4, 2001
TEC QA PDN PDN
PLANNING
establish formula
establish product
spec
RM QA
meeting with
supplier /
confirming quality
pilot
production
any problem ? no
yes
investigation / production
analysis planning
A 4 FBPT form
A 5 product specification
B 12 DR list
B 13 Others
A: essential B: if any
Received by QA date :
QA Mgr:
QA ISO Form No: QA/009i/2002.xls
Form updated date: 12/8/03
Procedure of FBPT
Product formula
Product spec
Test results
RM standard
(new/revised)
Wet paint lab sample
FBPT form
- objective
- detail
- precaution
- check b4 production
Standard cast-out
FBPT Meeting
judgement
NG
OK
NIPPON PAINT (S) CO. PTE. LTD.
S-R
Q-KY
If YES, please indicate Date Added to the Design Review Know-How Book :_____________
S - Subject; B - Background; H - Hypothesis; P - Plan/Procedure; R - Result; S-R - Observation; C - Comments; Q-KY - Quality Risk Prediction
CLASSIFICATION
I. problem code
II. problem outcome
III. batches involved
IV. volume involved
Note: This test report is for internal circulation only. This test report shall not be used in any way for any legal
litigation.
ACTION BY ASSIGNEE
Date:
By:
Action done in detail:
Note: classification
(I) Problem code
1 - Wet In-Can 2 - Application 3 - Paint Film
1.1 - Color 2.1 - Method 3.1 - Color
3.11 - color difference
3.12 - fading / discoloration
3.13 - yellowing
3.14 - patchiness
3.15 - others
1.2 - Viscosity 2.2 - Viscosity 3.2 - Adhesion / Peeling / Cracking
1.3 - Separation 2.3 - Dilution 3.3 - Drying time
1.4 - Settlement 2.4 - Opacity 3.4 - Opacity
1.5 - Odour 2.5 - Brushmarks 3.5 - Gloss
1.6 - In-can condition 2.6 - Brushability 3.6 - Chalking
1.7 - Others 2.7 - Others 3.7 - Others
(II) Problem Outcome
A Product non-conformance
B Applicator negligence
C Misunderstanding / miscommunication between parties
D Isolated & unexplainable case
RM QA GUIDE
Forbidden material
3. Storage Temperature range for store
Light resistance
Stability after storage
1. Delivered quality Standard and spec range
Testing standard
COA
2. Lot statement Shelf life
Interpretation of production date
3. Pack size & type of packaging Nett / Gross Weight per unit
Paper bag / Metal drum / Plastic pail
Any special tools to open the packaging
4. Labeling on container Photo of the material
RAW MATERIAL QA INFORMATION SHEET Usage
- Discussion material between supplier & QA
date - Check information item
I/C
name of RM
manufacturer
present supplier NPS
product formulated
results
circulation route I/C QA Mgr Tec Mgr Pdn Mgr Div I/C file
QA
DESIGN REVIEW KNOW-HOW BOOK
Type: A - Additive; M - Miscellaneous/Process; P - Pigment/Colorant; R - Resin; S - Solvent; SP - Semi-Product; FP - Finish Product Date Submitted:
Incoming Check
No. Type of RM SS COA only QC Test Storage stability Remarks
(per RM spec.) check
1 Additive V X X
2 Resin V V V
(min. 10 lots) (min. 3 lots)
3 Latex V V V
(min. 10 lots) (min. 3 lots)
4 Pigment V V X
(min. 10 lots)
5 Colorant V V V
(min. 10 lots) (min. 3 lots)
6 Al Paste V V X seek Tech assistance
(min. 10 lots)
7 Solvent V X X
8 Imported semi V V V
(min. 10 lots) (min. 3 lots)
- The above is subject to change if abnormality is feedback or observed
NIPPON PAINT (S) CO PTE LTD
INCOMING RM MONITOR
0 Name of RM :
1 Category :
2 Supplier :
3 Shelf Life (mths) :
4 General
date received :
batch no. :
physical goods location: in nps / supplier site
PO no. :
Receiving no. :
quantity received :
inspected by :
Category of First Batch Performance Validation Requirement please Guidelines on the no. of
tick supervisions by QA
a) new product validation required 1 small; 2 regular
b) new standard colors not applicable for NPS FBPT na
c) modified product validation required 1 small; 2 regular
d) raw material substitution no validation required 2 regular
e) change in work method / process validation required 3 regular
f) change in facility validation required 3 regular
g) others no validation required to be discussed
III. Judgement for 1st batch production according to the above results: OK / Not OK
a. Items to be predicted risks:
Date of Issue
Product Name
MO no.
Production Date
Batch Size
Trial No. 1st & / 2nd & / 3rd
Attended By
Distribution: QA ® PDN ® QA ® File (into Aichi Database for circulation to PDN & TECH)
QA ISO Form No: QA/009iii/2002.xls
Form updated date: 12/8/2003
NIPPON PAINT SINGAPORE CO PTE LTD
Date of Issue
Product Name
MO no.
Production Date
Batch Size
Trial No. 1st & / 2nd & / 3rd
1 Fineness; microns
2 Specific Gravity
3 Viscosity @25oC; Ku
4 Non-Volatile; %
5 Tinting Strength; %
6 Opacity; %
7 Gloss @60o or 85o; %
8 Wet Scrub; cycles
9 Touch Dry Time; hrs
10 Hard Dry Time; hrs
11 Storage stability:
1-day at room temp. in-can condition & viscosity
1-wk at 40oC oven in-can condition & viscosity
Distribution: QA ® TECH ® QA ® File (into Aichi Database for circulation to PDN & TECH)
QA ISO Form No: QA/009iv/2002.xls
Form updated date: 12/8/03
NIPPON PAINT SINGAPORE CO PTE LTD
TIMING VISUAL CHECK IN-CAN VISCOSITY FINENESS GLOSS COLOR PROBLEM ACTION FOLLOW-UP I/C
(KU) (microns) (60° & 85°) FOUND
t=0 spec: spec.: spec.: L
a
( / / ) b
t = 1 day sedimentation ( y / n ) dL
at room temp. gellation ( y / n ) da
in-can separation ( y / n ) db
( / / ) pH dE
t = 1 week sedimentation ( y / n ) dL
gellation ( y / n ) da
in-can separation ( y / n ) db
( / / ) pH dE
t = 1 mth sedimentation ( y / n ) dL
gellation ( y / n ) da
in-can separation ( y / n ) db
( / / ) pH dE
t = 2 mths sedimentation ( y / n ) dL
gellation ( y / n ) da
in-can separation ( y / n ) db
( / / ) pH dE
t = 3 mths sedimentation ( y / n ) dL
gellation ( y / n ) da
in-can separation ( y / n ) db
( / / ) pH dE
QA ISO Form No: QA/010/2001.xls Form updated date: 14/02/2011
FIRST BATCH PRODUCTION TRIAL RECORD SUMMARY 2015