Professional Documents
Culture Documents
Introduction
Requirements
AQL defined, OC curves, UQL defined
Lot Size and Common mistakes
Current Topics and Usage of AQLs
Final Thoughts
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Introduction
Acceptance Sampling uses statistical sampling to determine
whether to accept or reject a production lot of material.
Brief History
100% Inspection was (is) too costly
Became common during WWII, Mil-Std-105
Allowed buyers to make decision to accept or reject
Same principle for incoming materials for aseptic processing
100% Inspection Sampling after 100% inspection provides a final
Quality Control evaluation, tests the effectiveness of the 100%
inspection and may reveal special cause situations.
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Requirements/Sources
21CFR211.22 Responsibilities of quality
control unit
approve or reject all componentsdrug products
identity, strength, quality, and purity
21CFR820.250 Statistical Techniques
(a) Where appropriate, each manufacturer shall establish and maintain
procedures for identifying valid statistical techniques required for establishing,
controlling, and verifying the acceptability of process capability and product
characteristics.
(b) Sampling plans, when used, shall be written and based on a valid statistical
rationale. Each manufacturer shall establish and maintain procedures to
ensure that sampling methods are adequate for their intended use and to
ensure that when changes occur the sampling plans are reviewed. These
activities shall be documented.
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Uses
Sampling for incoming material release.
Tailgate sample, random sample*
*A sampling method in which all members of a group
(population or universe) have an equal and independent
chance of being selected.
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AQL Defined
Acceptance Quality Limit
The AQL is the quality level that is the worst tolerable
process average when a continuing series of lots is
submitted for acceptance sampling*
95%
Probability
of
Accepting
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What determines the plan?
Specifications
Required quality level
Destructive/non-destructive testing
Customer Expectations
Regulatory/Compendial Requirements
Acceptance Sampling Plan
ANSI Plans
Binomial Distribution
Evaluation of Risk (95% probability of accepting?)
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Acceptance Sampling Plans
The purpose of an acceptance sampling plan is to make
accept/reject or pass/fail decisions without evaluating all
units.
Reject/Fail Hold, reinspect, reprocess.
Accept/Pass Release.
This is a
probability
curve.
The probability
of accepting
goes down as
the defect rate
goes up.
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Important Points on the Curve
n=800 A=10.
AQL Point
95% Probability
Acceptance
Quality
Limit
UQL Point
5% Probability of
Acceptance (95%
Probability of
rejection)
Unacceptance
Quality
Limit
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AQL vs. UQL
Acceptance Quality Limit Represents the
percentage of defects routinely accepted.
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Protection that the plan provides
Sampling 800
and accepting
the batch with 10 95%+
units.
Routinely (95%
of the time)
accepts batches
that are <=0.77%
defective. >=2.1%
Routinely (95% <=0.77%
of the time)
rejects batches
that are >=2.1%
defective Note: AQL of 0.77% is true 95% value, if you use the ANSI/ASQ plan with a
Defect rate of 0.65% you would have a 98% probability of acceptance.
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Selecting Plans
ANSI/ASQ Z1.4 0.65% Plans
*Wayne Taylor
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Lot Size Influence
Lot size has very little to no influence on sampling plans.
A common
misperception
Because of standard
tables
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Lot Size Influence
1. Select Lot Size.
2. Sample size is
related to lot size.
3. Read Accept/Reject
Criteria.
XX WRONG XX
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Lot Size Influence
These are
Not valid
Defect Rate
1 in 800
Pass an AQL of 0.65%
Fail an AQL of 0.015%
We can infer from these samples
The same information.
Defect Rate
1 in 800
Pass an AQL of 0.65%
Fail an AQL of 0.015%
The quantity in the population
Is irrelevant to what we can infer
From the sample. 19
Recommendations
Understand the OC curves and protection
they provide for both AQL and UQL.
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Topics: Recommended Levels
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Thoughts
This should not be considered a target.
Comprehensive particle reduction is still regulatory
expectation.
The pre-requisite (after 100% inspection) contains a vast
amount of work.
Doesnt preclude the necessary particle
characterizations and elimination.
Opinion: Extrinsic and Atypical particles
95%
Probability of
Accepting
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Topics: Uses of tightened AQL.
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Topics: Uses of tightened AQL.
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Review
Acceptance Sampling is a method to evaluate quality
(and measure inspection effectiveness).
If you are failing your acceptance criteria, your quality is worse
than the AQL.
Quality must be established in the overall process, not by relying
on culling defects.
Understand the % defects that are routinely accepted
and routinely rejected by your sampling plans.
Evaluate capabilities vs. AQL levels for suppliers and
finished goods.
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Questions?
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