Document set of FBPT process

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

transfer a set of check formula &

doc/mat. to QA spec
transfer master

RM QA
meeting with
supplier /
confirming quality

set-up operating conditions / document PWS

meeting for trial production

issue PWS for MO for trial

trial production

pilot
production

report trial results

fbpt form

pilot production review meeting

any problem ? no

yes
investigation / production
analysis planning

first batch production in a full size

fbp report

final quality check

qualification of produced quality issue PWS on

other batch sizes
QA checking
ordinary production
Serial No.: FBPT/F-A15/00
To Dept: QA
Check List for Production Transfer To I/C :
Source :

subject : First Batch Production Trial

name of product :
objective :
remarks :

list of document transferred

no. document date tick remarks
received
A 1 product formula

A 2 standard color cast-out

A 3 wet paint lab sample

A 4 FBPT form

A 5 product specification

A 6 relevant abstract report

(with Q-KY)

A 7 formula & specification

history

B 8 raw material standard

B 9 new raw material approval

B 10 raw material MSDS

B 11 raw material comparison

B 12 DR list

B 13 Others

A: essential B: if any

Received by QA date :
QA Mgr:
QA ISO Form No: QA/009i/[Link]
Form updated date: 12/8/03
Procedure of FBPT

b4 FBPT TEC QA PDN

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

(new RM spec agreed)

Issue PWS with detail

- product ID
- formula
- spec
- instructions on:
-- method of pdn
-- machinery
-- process:sequence
-- process: mixing

FBPT Meeting

Aft FBPT Trial production

In-process & Final

Checking
Storage stability

Complete FBPT form

Report and share the

results

judgement
NG
OK
NIPPON PAINT (S) CO. PTE. LTD.

ABSTRACT CARD Reported by: Date:

Ref: ABC/INT/A15-

Approved by: Ref: ABC/PDF/A15-

S PDF No.:

S-R

Q-KY

Any Input to Design Review?: YES / NO

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:

Circulation route: QA → Assignee → QA

QA ISO Form No.: QA/014/[Link]

Form Updated Date: -

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

RM Type: Additive / Pigment / Colorant / Resin / Latex

item examples on the area to be confirmed

1. Characteristics in chemical structure IR, GPC, NMR, SEM, TEM, etc
composition

2. Type of functional group Function, distribution

3. Contermination Catalyst, residue, by-products
4. Water content
5. Intentionally added
1. Dynamism/mechanism of function Manner of function
2. Precaution on handling Range of dosage, temperature range during handling
Charging sequence
function

3. Safety Toxicity, hazard

Way of protection
MSDS
4. Moisture absorption
1. Cleaning production line Way of washing/cleaning
2. Prevention of foreign matters coming in Affect by contermination
processing

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

key parameters for QA aspect

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:

Production: What Need

Matters Observed and
Chemical Technical: What To Look to be Checked by
Product Name Type Outcome Which RM QA Info Source
Composition Out During Formulating Process Engr during
Required Attention
1st Lot
UCAR LATEX R-7030 R All Acrylic Copolymer Latex shock if pre-mix Latex cannot be used in premix To include temperature limit N.A DR04-002 Pei Ling
temperature is over the latex's stage. Need to confirm millbase and dispersion time of the
temperature limit ( > 50°C) or temperature of paint formula (to be premix process instructions in
when abraded < 50°C). the PWS
QC Plan on New RM

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 :

item test method spec result

In-can condition
Film Appearance
Fineness (microns)
Viscosity (Ku; 25°C)
Specific Gravity (25°C)
Non-Volatile (%)
pH
overall* pass / fail
batch decision* accept / reject
Movex QI Result* 1/2/3/4
Movex 110 completion* yes / no
* delete where necessary
QI Result denotion
1 - fully approved; 2 - conditionally approved with remarks; 3 - partially rejected; 4 - rejected
QA ISO Form No: QA/001/[Link]; Form Updated Date: 01/08/2001
Material prepared for First Batch Production Meeting

1 Product formula (i.e. formula history)

2 Product specification (i.e. past batch results)
3 FBPT Form (transfer materials)
4 RM status (RM-QA)
5 Prelab test results (Q-KY / DR)
6 PWS Scale-Up
7 MO ticket

Participants for First Batch Production Meeting

TECH - Chemist in-charge
PDN - Planner, Supervisor & Operator
QA
DISCUSSION POINTS ON FBPT MEETING

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

No. Item Detail Tick Conclusion

1 Usage / Objective Background on new product / modification
2 Technical data Abstract card relevant
3 Formulation Difference between existent equivalent
New raw material introduced; RM-QA
4 Specification Difference between existing spec.; batch results history
Prelab test results
5 Process & Precaution Batch size for 1st trial; PWS Scale-up on regular batch
Process method & instructions (Q-KY / DR)
Storage stability (parameters to monitor; duration)
Handling raw materials
6 Production schedule When to produce; where to pack
Deadline for completion of fbp results
No. of PDN trials to be supervised by QA
7 Demand Monthly
Minimum stock
By when
8 Obsolete material Raw material
Semi-products
Disposition of stock
9 Field test item / Performance validation
10 Cost
RECORD FOR PRE-LAB TEST
Name of Product:
Purpose of FBPT: FBPT Serial No.: FBPT/F-A15
Date:
Person in-charge:
Planned date of manufacturing:

(plse tick) Result

of checking DR List
no problem
prediction of defects: Sample date produced:
I. Properties inspection: Sample date received:
No. Test Item Spec Result Result Remark / Countermeasure
Tech QA
1 Paint condition
2 Fineness; µ
3 Cast-out appearance
4 Specific Gravity @25°C
5 Viscosity @25°C; Ku
6 Non-Volatile; %
7 Tinting Strength; %
8 Opacity; %
9 Gloss @60°; %
10 Gloss @85°; %
11 Wet Scrub; cyc
12 Color Acceptance Shaking
Test with YO (0.5% & 2%)
13 Color Acceptance Shaking
Test with RO (0.5% & 2%)
14 Other test:
15 Other test:
16 Other test:

II. Production method:

No. Description Result Remark / Countermeasure
1 Sufficient amount of initial water / resin
2 charge
Pigment content in pre-mix formula
3 P/V ratio
(total pigment wt in pre-mix formula) / (solid wt in
vehicle of pre-mix formula)

4 Selection of rinising solvents from formula

5 Sufficient water / solvent for rinising
6 Batch size for 1st batch

III. Judgement for 1st batch production according to the above results: OK / Not OK
a. Items to be predicted risks:

b. Countermeasure for the 1st batch production:

c. Solvents for rinse:

QA ISO Form No: QA/009v/[Link]

Form updated date: 23/9/03
NIPPON PAINT SINGAPORE CO PTE LTD

FIRST BATCH PRODUCTION TRIAL FORM

(I) PROCESS MONITORING

Serial No.: FBPT/F-A5/0

Date of Issue
Product Name
MO no.
Production Date
Batch Size
Trial No. 1st & / 2nd & / 3rd
Attended By

Process Items Result of Evaluation Problem Countermeasure

Premix stirring / mixing condition
viscosity; at 25°C
specific gravity; at 25°C
temperature
Grinding grinding machine / high speed dispersion
flow rate
# pass / grinding time / dispersion time
grind achieved
viscosity; at 25°C (by grinding method only)
temperature
remarks
Letdown stirring / mixing condition
grind achieved
viscosity (initial); at 25°C
viscosity (final); at 25°C
Total Process Time; hrs
Formulation diluent usage to scale-up formula
Material any defect
Packing type of filter used
yield / % loss
Human Skill follow as per QAPCT
Safety any safety concerns
Others

Evaluation (plse tick)

1. Production 1. Can be continued as it is

2. There is problem in workability and improvement is required
2. QA 1. The present conditions should be established and continued
2. Trial production should be continued. Monitor the next batch.
Memo

Distribution: QA ® PDN ® QA ® File (into Aichi Database for circulation to PDN & TECH)
QA ISO Form No: QA/009iii/[Link]
Form updated date: 12/8/2003
NIPPON PAINT SINGAPORE CO PTE LTD

FIRST BATCH PRODUCTION TRIAL FORM

(II) QUALITY EVALUATION

Serial No.: FBPT/F-A3/0

Date of Issue
Product Name
MO no.
Production Date
Batch Size
Trial No. 1st & / 2nd & / 3rd

No Test Item Spec MO no. MO no. MO no.

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

Overall Outcome Countermeasures

1. Parameters fallen within spec
2. Performance acceptable
3. Paint stability acceptable
4. Others
Conclusion / Remarks by QA:

Comments / Remarks by TECH:

Person In-Charge of Quality Evaluation:

Distribution: QA ® TECH ® QA ® File (into Aichi Database for circulation to PDN & TECH)
QA ISO Form No: QA/009iv/[Link]
Form updated date: 12/8/03
NIPPON PAINT SINGAPORE CO PTE LTD

FIRST BATCH PRODUCTION TRIAL FORM

PRODUCT STORAGE MONITOR SHEET

Serial No.: FBPT/F-A15-

Date of Issue Remarks:

Product Name
Color code
MO no. / Lot no.
Production Date (pls tick the storage location)
Batch Size Storage Location QA's Black Box
Trial No. 1st / 2nd / 3rd Tech's 40degC Oven
Checked by Tech's 50degC Oven
QC mgr Others:

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/[Link] Form updated date: 14/02/2011
FIRST BATCH PRODUCTION TRIAL RECORD SUMMARY 2015

Item 2015 2015 Jan Feb Mar Apr May

Cumulative %
No. of FBPTs conducted 0 -
Trial's Section:
Emulsion (EM) 0 ###
Enamel (EN) 0 ###
Objective of Trial:
New product / colors (NP) 0 ###
Modified product (MP) 0 ###
Raw material substitution (RM) 0 ###
Change of work mtd / process (WK) 0 ###
Change in facility (FA) 0 ###
Others (OX) 0 ###
PWS Creation (from 15 Aug'03)
PWS issued for FBPT 0 ###
Preparation of Trial 0
Production Preparation Meeting held 0 ###
Applying RM QA (New RM) 0 ###
Applying DR 0 ###
Application Of Q-KY 0 ###
Trial Outcome:
Passed in Workability 0 ###
Passed in Product Quality 0 ###
Passed in Workability & Product Quali 0 ###
Success Rate:
Passed 0 ###
Conditional acceptable 0 ###
Rework / Failed 0 ###
Failure cost if w/o FLC practice (S$) 0.00 #DIV/0!
Issues encountered during trial:
Procedure a) initial charge unable to 0 -
meet despa height

b) longer pre-mix dispersion 0 -

time

c) insufficient initial charge 0 -

=> premix too thick for
dispersn
d) others 0 -
Material quality of rm 0 -
Machine a) faulty machinery 0 -
b) power tripped 0 -
Formulation diluent qty extra required 0 -
differ from
Pdn scale-up extra 0 -
by > +/-3% remained
total 0 -
Specification all within spec 0 -
some test items out of spec. 0 -
Human Skill - 0 -

Note: Criteria for Passed in Workability:

- 1) Process instructions is acceptable
- 2) Formulation's water usage ≤ 5% to scale-up formulation
Jun Jul Aug Sep Oct Nov Dec