Page 25 - Sec02B

หมวดที่ ถุงมือนิรภัย ESTSAFE ®

02 SAFETY GLOVES BESTSAFE GLOVE CO.,LTD

THEORY OF GLOVES & TESTING METHOD BESTSAFE GLOVE CO.,LTD

AQL : ขีดจำกัดของคุณภาพที่ใชในการยอมรับ โดยตรวจสอบ
Chart 1. Operating Characteristic (OC) Curve
100
90
80 70 60
PERCENTAGE OF LOTS EXPECTED TO BE ACCEPTED 50 40 30 20

0 10
0.0% 0.6% 1.2% 1.8% 2.4% 3.0% 3.6% 4.2% 4.8% 5.4% 6.0% 6.6% 7.2% 7.8% 8.4% 9.0% 9.6% 10.2% 10.8% 11.4% 12.0% 12.6% 13.2% 13.8% 14.4% 15.0% 15.6% 16.2% 16.8% 17.4% 18.0% 18.6% 19.2% 19.8%
PERCENT DEFECTIVE IN SAMPLE SIZE OF 80
0.65 GII 0.65 GI 1.0 GI 1.5 GI 2.5 GI
AQL Standards: How is AQL determined and measured for gloves?

AQL is a pass/fail where a predetermined sample size of a manufactured
Surgical gloves are 0.65 (Natural Rubber Latex, or NRL) or 1.0 lot is tested following the sampling plan and protocols established by
(Non-Latex)*, meeting or exceeding world standards of 1.5 the various international standards or more stringent standards set by
Examination gloves are 1.5, meeting or exceeding world standards of 1.5-2.5 manufacturers to ensure stricter and higher quality is delivered to the
customer.
The lower the AQL, the lower the chance of finding a defect The sampling plan is an inspection procedure of a sample size (which
in the batch of gloves and the higher the quality of the product. are gloves that are randomly selected from a batch of gloves) that is
Table 1 : International Surgical and Examination Glove Standards used to determine acceptance or rejection criteria from an inspection
batch or lot. The sample size to be tested is set by:
Surgical Gloves Inspection AQL Examination Inspection AQL
Standards Level Gloves Standards Level The lot or batch size
AS/NZS 4179: AS/NZS 4011: The inspection level - determined by region as reflected in Table 1
2014 2 G1 1.0 2014 3 G1 1.5
Applicable to Australia/ Applicable to Australia/ AQL level specified in standards for the market or determined by
New Zealand New Zealand
individual manufacturers
ASTM 3577: ASTM D3578:
2009 4 2010 5 First the manufacturer will need to know
Applicable to US & the size of the lot being manufactured;
Canada ASTM D6319:
G1 1.5 2010 6 G1 1.5 this is the amount of gloves produced
ASTM D6977: without any conditions changing in a
2010 7 • 2 single run. Based on the lot size, the
Applicable to US & • standards will determine the sampling
Canada inspection, which is the number of gloves
EN 455 Part 1: EN 455 Part 1: • randomly selected to be tested. The
2000 8 G1 1.5 2000 8 G1 2.5 1 Litre = 2 Minutes gloves tested, according with Statistical
Applicable to the Applicable to the Quality Control, have all been through
European Union European Union
‘identical’ processing and are truly
ISO 10282: ISO 11193-1:
2014 9 G1 1.5 2008 10 G1 2.5 representative of the total lot or batch. In this test, the gloves are
Adopted by the rest of Adopted by the rest of
the World the World
JIS T9107: JIS T9115:
2005 11 G1 1.5 2000 12 G1 1.5 hung upside down for two minutes and checked for leaks (pin holes)
Applicable to Japan Applicable to Japan
under sustained pressure. This is the recognised test method for
Table 2 : Comparison Table for Selected AQL Sampling Plans global glove standards.
In Table 2, if the lot size is 10,000 (this is determined by the
AQL 0.65 1.0 1.5 2.5 manufacturer) and they are following an AQL of 0.65 with
inspection level 1 (determined by the standards), you will need to
Inspection select a sample test of 80 gloves. The full lot (10,000 gloves) can
Level G1 G1 G1 G1 be released if you find 1 or less defective gloves in the 80 gloves
(General Level I, GI)
inspected; that is equivalent to a maximum of 1.25% defective in the
Lot/ Batch 10,000 10,000 10,000 10,000 tested gloves. However, if your AQL is 1.5, as determined in the
Size majority of standards, your full 10,000 gloves lot will pass if you find
3 or less defective gloves in the 80 inspected; which is equivalent to
Sample Size 80 80 80 80 a maximum of 3.75% defectives in the tested gloves. This clearly
Maximum illustrates that a more stringent AQL ensure less defects in the
Non- overall lot.
Conformance 1 2 3 5 If there are more than the allowable number of defective gloves in
Number
Acceptable the sample size the lot will be rejected. The rejected lot will either be
discarded or 100% reworked through sorting and then checked
again for AQL.
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