ISO 12757

International Organization for

Standardization (ISO)

• Worldwide federation of national standards

bodies from some 90 countries
• ISO is a non-governmental organization
established in 1947 to facilitate and promote
the international coordination and
unification of industrial standards
• Ballpen and Rollerball – 1998
ISO 12757-2
1998
ISO 12756
Vocabulary
BP and RB

BALLPEN ROLLERBALL

ISO 12757-1 ISO 14145-1

General Use General Use

ISO 12757-2 ISO 14145-2

Documentary Use Documentary Use
ISO 12756 Vocabulary

Ball Pen
……writing fluid with a dynamic viscosity greater
than 1000mPas at 23C +/-2C

Rollerball
…..writing fluid with a maximum dynamic viscosity
of 1000mPas at 23C +/-2C
12757-1 General Use Ballpen
1 Tip Classification
EF Diam <0.65mm
F 0.65<= Diam <=0.85mm
M 0.85<= Diam <1.05mm
B1.05<= Diam

2 Shapes & Dimensions of Refills

Classified into 7 types according to shape and
dimensions
A,B,D,E,F,G and H
3 Performance (std atmosphere :‘23/50’ )
a Writing
(>=10 refills; write 5m; rest 3h; write 300m min; 20cm restart)
b Strike through
(climatise 24h)
c Drying time

(20s; 45+/-5 Shore A eraser)

d Reproducibility
e Water resistance
(climatise 2h; immerse 1h)
f Light resistance

(BW3 = GS4)
g Shelf life

(store 90 days @ 40C/55%RH; then test writing)

4 Equipment
a Write-test machine
- Point load1.5N +/- 0.1N
- Writing angle 75 degrees +/- 5 degrees
- Writing speed 4.5 m/min +/- 0.5 m/min
- Circular 100mm circ; pitch 1-5mm
b Paper
- Grammage 80 +/- 5 g/m2
- Smoothness 3um +/- 0.25um
- Ash 11% +/- 1%
- Cobb60 20 +/- 3 g/m2
- Thickness 80 +/- 5um
- Color White
- Composition 100% wood cellulose fibre, bleached
5 Designation

Point size

ISO 12757-1 A F

Type

Plus
• name of manufacturer
• date of manufacture
12757-2 Documentary Use Ballpen
As 12757-1 General Use Ballpen, PLUS resistance to….

a Erasure
(rest 10min; erase with 45 Shore A eraser)
b Ethanol
(rest 1h; immerse (50% soln) 10 min)
c Hydrochloric acid
(rest 1h; immerse (10% soln) 24h; rinse/dry)
d Ammonium hydroxide
(rest 1h; immerse (10% soln) 24h; rinse/dry)
e Bleaching solution
(rest 10min; immerse (3% chloramin T soln) 5min; rinse/dry)
f Water
(rest 2h; immerse 24h)
g Light
(BW5 = GS4)
Designation

Point size

ISO 12757-2 G2 M DOC

Documentary Use
Type
ISO 12757-2
Light

Water

Ethanol

Hydrochloric
Acid

Ammonia

Chloramin-T

Erasure

Original Exposed Original Exposed

Dokumental Ink
Static Leakage
Static Tip-Leak
• Tests are conducted both at high
temperature/humidity and under ambient
conditions
- High: 45°C +/- 0.3°C and 85% +/- 1.5% RH
- Ambient: 24°C +/- 1°C and 55% +/- 10% RH
• The test is conducted for 72 hours for High and
7 days for Ambient
Static Tip-Leak Procedure
• Clean the tips with tissue paper
• Visually assess if there is any rim damage
• Write 5 loops with each refill
• Group refills together in a batch of 10 refills,
holding them together firmly with tape or
elastic
• Hang the grouped refills vertically tip-down in
the test chamber with the tip free from contact
with any surface
Static Tip-Leak Procedure
• Leave the refills tip-down for the required time
• At the conclusion of the test, observe the
presence of an ink drop on the tip and record a
rating as outlined below (take a photographic
record for the report)

Rating Description
4 No drop on tip
3 Small drop on tip
2 Medium drop on tip
1 Large drop on tip

Photographic reference standard should be available

Static Back-Leak
• Tests are conducted both at high
temperature/humidity and under ambient
conditions
- High: 45°C +/- 0.3°C and 85% +/- 1.5% RH
- Ambient: 24°C +/- 1°C and 55% +/- 10% RH
• The test is conducted for 72 hours for High
temperature storage and 7 days for Ambient
temperature storage
Static Back-Leak Procedure
• Clean the tips with tissue paper
• Visually assess if there is any rim damage
• Write 5 loops with each refill
• Group refills together in a batch of 10 refills,
holding them together firmly with tape or
elastic
• Hang the grouped refills vertically tip-up in the
test chamber with the end of the refill tube
free from contact with any surface
Static Back-Leak Procedure
• Leave the refills tip-up for the required time
• At the conclusion of the test, observe the
presence of an ink and/or follower leaked from
the rear of the tube and record a rating as
outlined below (take a photographic record for
the report)
Rating Description
3 No back leakage and no
ink movement
2 No back leakage but ink
movement
1 Back leakage
ISO 2859 & Sampling
ISO 2859 – Single Sampling Plan
• ISO 2859 is an internationally recognized
standard that specifies an acceptance sampling
system for inspection by attributes important to
the customer/buyer/end-user
• It is indexed in terms of the acceptable quality
level (AQL)
• AQL’s are normally established considering
requirements of the industry, what’s perceptible
by the end user, supplier’s experience, and costs
An Objective Measurement of Quality
• In most product categories, there will be defective
products in virtually every production batch
- Even after a manufacturer has checked each individual
product (since visual inspection is not 100% reliable)
• In many supplier/buyer relationships (particularly
when the product does not result in life or death),
the supplier is not expected to deliver defect-
free goods
- The buyer needs to control the quality of purchased
goods, since he does not want too many defects
Defects

• All defects are not equal. Defects, depending on

their size and type, have different probabilities
of impacting the finished product
• Many defects are simply neutral. They are never
good, but they may cause no harm either
Quality Plan Process

Identify Key Attributes

Apply AQL’s for Critical, Major, Minor defects

(create reference photographs of ‘acceptable’ and ‘unacceptable’)

Determine the Inspection Level

Determine what represents a ‘Production Lot’

View AQL Tables to determine Sample Size

Accept or Reject the lot based on Table data

Key Attributes Important to Customer
• Acceptance criteria are based on the customer’s
perspective
• For tips the most important customer attributes
are:
- ILD
- Key physical dimensions allowing the tip to fit
their refill correctly
- Ball loss
- Others?
Key Attributes Important to Customer
• There are a host of other parameters that CRI
measures and controls that allow it to satisfy
what’s important to the customer
- But these, in and of themselves, are of no interest to
the customer, but they still need to be consistently
controlled
Acceptance Quality Levels
• ‘Quality level that is the worst tolerable’
• AQL’s are applied in order to evaluate
conformity of a given production batch of tips

Class of Defect AQL

Minor 4.0

Major 1.0

Critical 0.15
What’s the Right AQL?
Driven by Two Factors:
Market
• The most common AQL’s are 2.5 for major defects,
4.0 for minor defects, and 0.15 for critical defects.
This is the ‘standard’ tolerance for most consumer
products sold in North America and Europe.
User risk
• For car & plane parts, and for pharmaceuticals, the
accepted defect rate is much lower than 1%. That’s
because a defective part might cause death
AQL’s
• 0.15% for critical defects
- totally unacceptable: a user might get harmed, or
regulations are not respected
• 2.5% for major defects
- these products would usually not be considered
acceptable by the end user
• 4.0% for minor defects
- there is some departure from specifications, but
most users would not mind it
Strict AQL’s
• Very strict AQL requirements may affect the
pricing offered by a supplier, because a higher
likelihood of rejected products or the need to
rework items will cause them to bear higher
costs
• Some suppliers may even be unwilling to
manufacture products at what they consider
unreasonable AQL requirements
‘Zero Defects’
• Statistically speaking, literally zero defects
corresponds to a defect level of infinity sigma,
which most statisticians and quality experts say
is not possible
• But a ‘zero defects’ program pushed by some
industries may promote the belief and
expectation that ‘zero defects’ can and should
be achieved
‘Zero Defects’

• ‘Zero Defects’ is more an attitude or mindset,

demanding a process of continuous
improvement to reduce variation in production

‘Strive to Be Better and Better,

Not Necessarily Perfect’
Some Perspective
• Condom Leakage
- 0.4 AQL (i.e. 4 out of every 1000 are allowed to
leak!)
• Medical Surgical Gloves Leakage
- 2.5 AQL for USA and International (non-EU)
- 1.5 AQL for EU
• Some Aircraft Parts
- Minor AQL: 2.5
- Major AQL: 0.65
- Critical: 100% inspection
Some Perspective

• ‘Mean Time Between Failure’ is another

measure of Quality
• Space Shuttle software is designed to fail less
than once per century
• Windows software is designed to fail less
than once an hour!
Inspection Levels

• It is usually the buyer’s responsibility to select

the inspection level
• More samples to check means more chances to
reject products when they are defective, but it
also means more time (and money) spent in
inspection
Inspection Levels
Level I
• Has the supplier passed most previous inspections? Is there confidence in their
products quality? Instead of doing no quality control, inspectors can check less
samples by choosing a Level-I inspection.
• But choosing Level-I by default (for time/costs reasons) can be risky: the
potential for finding quality problems is lower than typically recommended.
Level II
• It is the most widely used inspection level, typically used by default.
Level III
• If a supplier recently had some quality problems, this level is chosen, with more
samples being inspected to help regain confidence in supplier quality

Level-II is typically used

Level-I is used when less discrimination is required
Level-III is used when greater discrimination is required
A ‘Production Lot’
• Consists of items of a single type, grade, class,
size and composition, manufactured under
uniform conditions at essentially the same time
• A homogeneous collection of units of product
from which a representative sample can be
drawn
• May consist of several batches – homogenous
meaning batches of products made in groups
and from the exact same parameters
AQL Tables
AQL Tables are statistical tools for product
inspections. They help determine two key
elements:
• How many samples should be inspected?
• Where is the limit between acceptability and
refusal, when it comes to defective products?
AQL Tables: Sampling Codes
Single Sampling Plan for Normal Inspection
CRI Quality Checks
• Tip production
- Key physical dimensions and inspection process
• Functional tip performance
- Key writing characteristics
- Manual-writing – does it qualitatively make
an appropriate mark on paper?
- Machine-writing – does it deliver the
expected ILD, writing quality, and leakage
control?
Tip Production
• Key dimensions measured & controlled:
- Finished rim thickness
- Spin angle
- Finished ball protrusion
- Last back hole depth
- Ball-play
- Overall length
- Capillary hole diameter
- Ball seat diameter
- Broach diameter, depth, and spline width
Process Review
• Based on our review, we can assume that a
production lot is (on average) 100,000 tips per
machine per day
• Using the Sample Coding Table the number of
sample tips for Inspection Level-I per
production lot (i.e. per machine per day) should
be 200
Accept/Reject

• Major Defect AQL of 2.5

- Reject production lot if you find more than
10 defective tips on ILD and/or key fit
dimensions
• Critical Defect AQL of 0.15
- Reject production lot if you find more than 1
defective tip with a critical defect
Process Improvements
• Ink storage
- Quantity
- Location
• Ink properties
- Rheology or supplier data
• Refill assembly processes for testing
- Filling
- Centrifuging
- Testing (and data storage)
- Environment