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VCA - Impact Resistance Testing Progam
“10 easy steps to implement
a low cost system”
Simple & Minimal Cost
20 Lenses Each Week
Virtually no Lens Cost
1 Hour Per Week Labor
Define Your Test Batch
Wide Latitude from FDA 1 day or 1 week Batch Size
1
Batch Size & Inspection Level
Begin with General Level II Z1.4 table I Specifies Sample Size
2
The Correct Sample Size for the Batch
Why we use a 6.5 AQL Using table II
Determines lens quantity Acceptable number of failures
200 lenses/day example:
3
Sample Size
Lens production Testingper day Lenses /day Can fail
90 13 2150 20 3280 32 5500 50 71200 80 103200 125 14
First 10 days of testing
Selecting Lenses for Test
“Random sampling” is easiest
Matching your sales mix
4
Minimize Cost with Confidence
Daily General Level II for 10 days
Move to S-4 with confidence Redefine the batch to 1 week Example:
5
Sample Size
Lens production Testingper week Lenses /week Can fail
280 13 2500 13 21200 20 33200 32 5
10000 32 535000 50 7
Regular weekly testing
Batch size of 200 lens per day
General Level II, daily testing– 32 lenses tested– 5 lenses can fail in acceptable batch
S-4, weekly testing– 20 lenses tested– 3 lenses can fail in acceptable batch
Who Tests AR Coated Lenses
Samples must be made for test Either party can test Combining your testing reduces
costs
6
Documentation Required
Record your batch definition Record test results regularly
Who, when, # samples, pass or fail Test log example:
7
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
Test Log Page
Suggestions Beyond The Regulation
Individual Lens Failures
Individual lenses may fail Identify the product and inspect it Make notes to discover trends
8
What if a Batch Fails
Inspect the failures Retest or go back to general level II Retain the failures Consult your suppliers
9
Isolate Problem Products
Suspend shipment of this product Test this product separately Qualify this lens by general level II
10
What permits the FDA test to be simple and inexpensive?
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
The final processor must test– This has not changed since 1972
Contact your lens manufacture
How can testing be this simple and inexpensive?
Sampling plan allows small sample size
Reject lenses are AR coated for test; no cost
No cosmetic damage to most lenses
FDA Intended lenses be tested and sold
Packaging Statement
"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
VCA members are confident this Program meets FDA testing requirements
Lens manufacturers’ technical experts willing to assist labs
We Can Help