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METAPHYSIS
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Systematic inspection
(unit)
|
Statistic inspection
(99 %
reliability grid)
|
Parameter
Inspection
|
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MATERIAL
|
TA6V
ELI
|
ISO and ASTM (USA
standard) compliance documentary checks
|
Material sampling
and analysis by approved lab.
|
.
.
|
|
Chemical
composition check
|
Chemical
composition check
|
|
Mechanical traction
and strech at break resistance check
|
Mechanical traction
and strech at break resistance check
|
|
Grain size
test
|
Grain size
test
|
|
|
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FORGE
|
.
|
Compliance forge
parameters (temperature, thermal treatments, strike
power)
|
Geometric check by
drawing
|
.
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Grain size test
after forge and thermal treatment
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|
|
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TURNING
|
Inter
|
First part setting
dimensional test
|
.
|
.
|
|
exter
|
Full dimensional
and three dimension machine geometry test, 2 micron
accuracy
|
1 part out of 10 in
process check by production operator using a
micrometer, calliper, gauge
|
Digital control
machine programmes
|
|
Unit cones check
(diameter and angle) by an electro-pneumatic
system
|
Random daily check
by quality control with its own measuring
instruments (possible detection of calibration
error in production's control instrument)
|
.
|
|
Microfiletage
inspection of the cone with a profile
projector
|
|
|
|
POLISHING
and ANODIZATION
|
.
|
.
|
Visual inspection
according to standards
|
Pressure, tie and
abrasion load quality parameter inspection
|
|
|
|
HAP
|
.
|
Powder batch check
according to ISO standard
|
Thickness
inspection
|
Pressure, plasma
speed, temperature inspection
|
|
Heavy metal
%
|
Crystalline phase %
control on deposit
|
|
Crystalline phase
%
|
Porosity
check
|
|
Tear
resistance
|
Unit visual
inspection
|
|
Coating
peak-to-valley
|
|
|
|
CLEANING
|
.
|
.
|
Part bacterial
contamination check
|
Periodical cleaning
water inspection
|
|
Chemical
contamination check (for NA, Nitrates,
hydrocarbures)
|
Rinsing water ultra
violet treatment efficiency check
|
|
|
|
GAMMA
STERILISING
|
.
|
.
|
Initial
contamination inspection according to
pharmacopoeia
|
Parameter
irradiation dose check
|
|
Process validated
according to ISO standard
|
Part sterilisation
check
|
|
Blister pack
stripping
|
|
Blister pack
sealing check
|
|
Shell and tyveck
thickness inspection
|
|
|
|
LABELLING
|
.
|
Production quantity
check at each step in order to identify possible
mixes
|
Unit weighing
inspection (for size error)
|
.
|
|
|
|
DIAPHYSIS
|
|
|
|
Systematic inspection
(unit)
|
Statistic inspection
(99 %
reliability grid)
|
Parameter
inspection
|
|
|
|
|
|
|
|
MATERIAL
|
TA6V
ELI
|
ISO and ASTM (USA
standard) compliance documentary checks
|
Material sampling
and analysis by approved lab.
|
.
|
|
Chemical
composition check
|
Chemical
composition check
|
|
Mechanical traction
and strech at break resistance check
|
Mechanical traction
and strech at break resistance check
|
|
Grain size
test
|
Grain size
test
|
|
|
|
TURNING
|
Inter
|
First part setting
dimensional test
|
.
|
.
|
|
exter
|
Full dimensional
and three dimension machine geometry test, 2 micron
accuracy
|
1 part out of 10 in
process check by production operator using a
micrometer, calliper, gauge
|
Digital control
machine programmes
|
|
Random daily check
by quality control with its own measuring
instruments (possible detection of calibration
error in production's control instrument)
|
|
|
|
POLISHING
and ANODIZATION
|
.
|
.
|
Visual inspection
according to standardised sets
|
Abrasive filler
quality time and pressure parmeter check
|
|
|
|
CLEANING
|
.
|
.
|
Part bacterial
pollution check
|
Regular cleaning
water check
|
|
Chemical
contamination check (for NA, Nitrates,
hydrocarbures)
|
Rinsing water
ultraviolet treatment efficiency check
|
|
|
|
GAMMA
STERILISING
|
.
|
.
|
Initial
contamination inspection according to
pharmacopoeia
|
Parameter
irradiation dose check
|
|
Process validated
according to ISO standard
|
Part sterilisation
check
|
|
Blister pack
stripping
|
|
Blister pack
sealing check
|
|
Shell and tyveck
thickness inspection
|
|
|
|
LABELLING
|
.
|
Production quantity
check at each step in order to identify possible
mixes
|
Unit weighing
inspection (for size error)
|
.
|
|
|