Transcript VCA - Impact Resistance Testing Plan

VCA - Impact Resistance
Testing Progam
“10 easy steps to implement
a low cost system”
Simple & Minimal Cost
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20 Lenses Each Week
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Virtually no Lens Cost
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1 Hour Per Week Labor
1
Define Your Test Batch
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Wide Latitude from FDA
1 day or 1 week Batch Size
2
Batch Size & Inspection Level
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Begin with General Level II
Z1.4 table I Specifies Sample Size
3
The Correct Sample Size
for the Batch
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Why we use a 6.5 AQL
Using table II
 Determines lens quantity
 Acceptable number of failures
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200 lenses/day example:
Sample Size
First 10 days of testing
Lens production
per day
90
150
280
500
1200
3200
Testing
Lenses /day
13
20
32
50
80
125
Can fail
2
3
5
7
10
14
4
Selecting Lenses for Test
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“Random sampling” is easiest
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Matching your sales mix
Minimize Cost with
Confidence
5
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Daily General Level II for 10
days
Move to S-4 with confidence
Redefine the batch to 1 week
Example:
Sample Size
Regular weekly testing
Lens production
per week
280
500
1200
3200
10000
35000
Testing
Lenses /week
13
13
20
32
32
50
Can fail
2
2
3
5
5
7
Batch size of 200 lens per day
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General Level II, daily testing
– 32 lenses tested
– 5 lenses can fail in acceptable batch
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S-4, weekly testing
– 20 lenses tested
– 3 lenses can fail in acceptable batch
Who Tests AR Coated
Lenses
6
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Samples must be made for test
Either party can test
Combining your testing reduces
costs
7
Documentation Required
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Record your batch definition
Record test results regularly
 Who, when, # samples, pass or fail
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Test log example:
Test Log Page
Test Party Date
Sample Size Pass/Fail
Joe Smith
03/08/02
20
P
Joe Smith
03/15/02
20
P
Joe Smith
03/22/02
20
P
Suggestions Beyond
The Regulation
8
Individual Lens Failures
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Individual lenses may fail
Identify the product and inspect it
Make notes to discover trends
9
What if a Batch Fails
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Inspect the failures
Retest or go back to general level II
Retain the failures
Consult your suppliers
10
Isolate Problem Products
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Suspend shipment of this product
Test this product separately
Qualify this lens by general level II
What permits the FDA test to
be simple and inexpensive?
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Does not cosmetically damage most lenses
– Hard coated lenses with AR coating?
FDA intended for good product to be tested and sold
FDA excludes Flat Tops
– Title 21 CFR 801.410 c(3) states
– “... Raised multifocal lenses shall be impact resistant
but need not be tested beyond initial design testing.”
The FDA is Clear
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The final processor must test
– This has not changed since 1972
Contact your lens manufacture
How can testing be this
simple and inexpensive?
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Sampling plan allows small sample size
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Reject lenses are AR coated for test; no cost
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No cosmetic damage to most lenses
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FDA Intended lenses be tested and sold
Packaging Statement
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"As a component, lenses of this design have
been shown by testing to be capable of
being processed to meet applicable Impact
Resistance requirements of FDA regulation
21 CFR 801.410. Conformance to this
standard is the responsibility of all
subsequent processors. Impact Resistant
lenses are not unbreakable. Obviously
damaged lenses should be replaced
immediately."
How Easy is This!
VCA Impact Testing Program
• Weekly testing of a few lenses
• Random sampling
• Low cost for lenses and labor
We Can Help
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VCA members are confident this Program
meets FDA testing requirements
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Lens manufacturers’ technical experts willing
to assist labs