Statistics in Validation

Statistics In Validation
Sampling Plans that Result in

Statistical Confidence
Jacalyn L. Schroeder
Statistician, Validation/Quality
Engineering Specialist
Medical Products
Strong Presence in Many Segments

PURIFICATION
PHARMACEUTICALS
HEALTH INFORMATION SYSTEMS
DENTAL
DRUG DELIVERY
SYSTEMS
PERSONAL CARE
AGENDA
Acceptance Sampling Plan Basics
Sampling Plans to Meet Validation
Objectives
Sampling Plans and Statistics
Throughout Validation Lifecycle
Interactive Exercises (Throughout)
J.L. Schroeder , 3M, March 2014
Acceptance Sampling
Plan Basics
Sampling Plans
A sampling plan is a
procedure for making
accept/reject decisions:
Take 300 samples from a lot
and accept if there are zero
defects
Includes both a sample size

and acceptance criteria
Resource: Dr. Wayne Taylor
Validation Sampling Plan Class 2008
Basic Sampling Plan

(For Percent Defective or Proportion Nonconforming)
Take a representative
sample of n units
Count the number

that are defective
Count a
ACCEPT
Compare
count to
accept
number
a
Count > a
REJECT
J.L. Schroeder, 3M, March 2014
N=100
Sampling Plan Selection

1. Determine sampling plan
purpose
2. Determine requirements to inspect for
Free of Red Stripes
Specifications Must Define
3. Determine appropriate statistical

performance property (i.e. percent
defective, defects per quantity, etc)
4. Choose sampling risks and acceptable quality
level and reject performance level
Sampling Plans
Devised to serve different purposes:
Neubauer Acceptance
Sampling Facts
OC Curve and Two Points

(AQL, 1-)
(LTPD, )
Specify a Plan
Two points on OC Curve (AQL, 1-) (LTPD, )
Four values may be used to characterize the
OC curve
AQL = Acceptable Quality Level
RQL or LTPD = Reject Quality Level or Lot
Tolerance Percent Defective
= Producers Risk
Sampling Risks
= Consumer Risk
Every Sampling Plan Has Its Own OC

Curve
Probability Pass
1
Single: n=30, a=0
Single: n=300, a=0
0.5
Single: n=3000, a=0
0
0
10
Percent Defective
Validation Sampling Plan Class
- 2008
Determine the chances

of passing at different
defective rates.
Every Sampling Plan Has Its Own OC

Curve
0.18
~25%
Sampling Plans and Risk

Sampling involves risk that the sample will not adequately
represent the entire population
Producers =0.05
Consumers
= 0.05
(AQL, 0.95)
(LTPD, 0.05)
Sampling Risk
Summary
Purpose of a sampling plan is to make
accept/reject decisions
Sampling Plans can serve many different
purposes (i.e. consumer/producer
protection, compliance sampling)
Every sampling plan has its own OC curve
that defines protection
OC Curve Defined by Two Points
(AQL, 1-)
(LTPD, )
Sampling Plans to Meet

Validation Objectives
Sampling Plans for Validation

Accept = Pass validation study
and go into production
Reject = Fail validation study and

must improve the product or
process
Regulations and Sampling Plans

Per 21 CFR 820.250 Sampling plans, when used,
shall be written and based on a valid statistical
rationale
Sampling Plans must appear in writing
Assumptions on which sampling plans are based
shall be verified
We should understand how the sample is taken
(random, stratified, periodic) to represent lot
For validation we want a sample to represent
production
Representative Sample
Obtaining a representative sample for
validation is more difficult than obtaining a
representative sample in manufacturing
Want sample that is representative of all
, not just one lot:
3 lots
Manufactured under what regulations call
anticipated conditions (material lots,
operators, setups, tooling, )
Objective of Validation
Demonstrate that the product or process
consistently meets pre-determined
performance requirements
A sampling plan can be used to demonstrate
that a required performance level is met with
certain confidence (AQL, LTPD, alpha, beta)
What is AQL?
What is routinely accepted
AQL
The AQL (Acceptable Quality Level) of a

sampling plan is a level of quality (percent
defective, defects per hundred units, etc.)
routinely accepted by the sampling plan
Products or processes at or better than the
AQL are passed at least 95% (1-)% of the
time
What is LTPD (AKA RQL)?

What is routinely rejected
.05 or .10
LTPD
The LTPD (Lot Tolerance Percent Defective) of

a sampling plan is a level of quality (percent
defective, defects per hundred units, etc.)
routinely rejected by the sampling plan
Products or processes at or worse than the
LTPD fail most of the time
Determine confidence statements
Confidence Statements
Validation sampling plans are designed to
demonstrate that the product or process
meets a specified performance level with
certain confidence:
Confidence Statement General Form:
With 95% confidence the requirement is
met
Confidence Levels must be documented in validation procedures
Performance Levels [LTPD.05] for PQ

Commonly used in pharmaceutical and
medical device industries for disposables
are:
For
Defect (Health and Safety)
0.065%, 0.1%
For
Defects (Functional)
0.25%, 0.4%, 0.65%, 1.0%
For
Defects (Cosmetic)
2.5%, 4.0%
Performance Levels must be documented in validation procedures
Summary
A sampling plan can be used to
demonstrate that a required
performance level is met with certain
confidence
Passing the plan n=300, a=0 allows one to
state: With 95% confidence the defect
level is below 1% defective.
PV SOP procedure to define

recommended performance and
confidence levels
Summary
(AQL, 0.95)
= =0.05
95% Confidence statement

(LTPD, .05)
AQL=.72
LTPD.05=9.1
Sampling Plans and

Statistics
Throughout the
Validation Lifecycle
General Validation Roadmap
Design/Process
Development
Validation Plan
Installation Qualification
Document (IQ)
Operational Qualification
Document (OQ)
Statistically Designed
Experiments
Performance Qualification
Document (PQ)
Cont. Process
Verification
Design
Qualification
Risk
Assessment
Equipment
Qualification
Design
Verification
- PPU
Process
Validation
Control
Validation Sampling Plans

Steps for sampling plan selection and
execution
1. Determine Protection Required
2. Select Best Sampling Plan
3. Document Sampling Plan and Analysis
Methods in Protocol
4. Execute Sampling Plan given in Protocol
5. Document Results and Conclusion in Final
Report
Resource: Taylor Enterprises
Statistical Procedures For
Medical Device Industry 2013
Step 1:
Determine Plan Protection

(Document in SOP)
Validation Sampling Risks
Recommend: =0.05, =0.05
Performance Levels at LTPD (LTPD.05)

Performance levels should be commensurate with
the risk associated with the characteristic
Performance Levels at LTPD.05
Risk
Critical
Major
Minor
Resource: Taylor Enterprises

Statistical Procedures For
Medical Device Industry 2013
OQ
5% (95% Conformance)
10% (90%
Conformance)
20% (80%
Conformance)
PQ
Step 1: Determine Plan Protection
Make Confidence Statement

Make Confidence Statement based on chosen
plan protection
If validation passes, one can be 95% (1-)
confident that process is below the LTPD0.05
(performance level)
Key Points
In order to pass a validation study
,
the process must be significantly
better than the validation performance level
Two Questions You Should Always Ask:

Answered by LTPD:
If I pass the validation study, what confidence
statement can I make?
Answered by AQL:
If my process is good, what are the chances of
passing the validation study?
Interactive Excercise
The table shows how the sample size depends on the
selected performance level and confidence level
IN CLASS EXERCISE ANSWER THE FOLLOWING:
With 95% confidence the defect rate is below 5% defective. How
many samples free of defects does this require?
With 90% confidence the defect rate is below 1% defective. How
many samples free of defects does this require?
This table is for attribute data, which gives larger sample

sizes. Use of variables sampling plans can result in lower
sample sizes.
Single Sampling Plans With a=0
Resource:
Dr. Wayne
Taylor
Validation
Sampling
Plan Class 2008
Performance Level
90% Confidence Meet

Performance Level
95% Confidence Meet

Performance Level
20%
n = 10, a = 0
n = 14 , a = 0
10%
n = 22, a= 0
n = 28 , a = 0
6.5%
n = 34, a = 0
n = 45 , a = 0
5%
n = 45 , a = 0
n = 60 , a = 0
4%
n = 56 , a = 0
n = 75 , a = 0
3%
n = 75 , a = 0
n = 100 , a = 0
2.5%
n = 90 , a = 0
n = 120 , a = 0
1.5%
n = 150 , a = 0
n = 200 , a = 0
1%
n = 230 , a = 0
n = 300 , a = 0
0.65%
n = 350 , a = 0
n = 460 , a = 0
0.4%
n = 575 , a = 0
n = 750 , a = 0
0.3%
n = 770, a = 0
n = 1000 , a = 0
0.25%
n = 920 , a = 0
n = 1200 , a = 0
0.15%
n = 1530 , a = 0
n = 2000 , a = 0
0.1%
n = 2300 , a = 0
n = 3000 , a = 0
0.065%
n = 3540 , a = 0
n = 4600 , a = 0
Step 2:
Select Sampling Plans

Choose Attribute or Variables Plans
Digress
Use Validation Sampling Plan Tables

(www.variation.com)
Attribute Sampling Plans

Choose between single or multiple
sampling plans at same performance
level
Multiple sampling plans were invented
to give questionable populations
another chance in order to better
understand the true proportion
defective
Double Sampling Plan

(For Percent Defective or Proportion Nonconforming)
START
Take a representative
sample of n1 units and
count number of defectives
Count a1
Compare
count
ACCEPT
Count r1
Take second representative

sample of n2 units and
count the total number of
defectives in both samples
REJECT
Continue To Second Stage

Count a2
ACCEPT
Compare
count
Count > a2
REJECT
Interactive Exercise
Which LTPD.05 Plan is Best?
1
Pa
AQL HigherChances of
Passing Are Better
0.5
0
0
Percent Defective

Defective/Nonconforming Units
Single: n=300, a=0
Single: n=630, a=2
Double: n1=325, a1=0, r1=3, n2=580, a2=3
LTPD = 1%
(Attribute 95% Confidence)
Sampling Plan
AQL
LTPD0.05
n=300, a=0
0.02%
1%
n=470, a=1
0.08%
1%
n1=325, a1=0, r1=2, n2=400, a2=2
0.09%
1%
n=630, a=2
0.13%
1%
n1=325, a1=0, r1=3, n2=580, a2=3
0.15%
1%
n=770, a=3
0.18%
1%
n1=325, a1=0, r1=3, n2=720, a2=4
0.18%
1%

Variables Sampling Plan

Variables data:
Coat Weight
Seal Strength
Assumptions:
Representative Sample
Measurements are Normally Distributed:
Should formally test for normality
Multiple lanes, multiple positions, may cause
non normal data sublott by position
Transform data to normal or find best non
normal distribution
Variables Sampling Plan

Use normal distribution to predict the
percentage of units outside of spec
USL
LSL
2.3%
Out of Spec
50
51
52
53
54
Fill Volume (ml)

55
Estimated Process Capability

Voice of Customer Nearest Spec Ave
Ppk =
=
3
Voice of Pr ocess
Numerator
LSL
Denominator
Target
USL
Interpreting Ppk
Ppk

Defect Level)
1.5
Distance From
Spec
4.5
1.33
32 dpm
1.167
3.5
233 dpm
0.14%
0.833
2.5
0.62%
0.78
2.3
0.89%
0.67
2.3%
0.5
1.5
6.7%
3.4 dpm
Procedure For Variables Sampling Plans

START
Take a representative sample of n units,
measure each unit and calculate
average (X) and standard deviation (S)
Calculate Ppk
Is Ppk Ppk
ACCEPT
Yes
No
REJECT
Normality Assumption
Requires separate normality test
Normal probability plot or histogram alone
are not enough.
Data must be in control for future process
predictions.
Step 2:

(www.variation.com)
Select BEST Sampling Plan
Compare samples sizes and AQLs to determine
best choice at a specified performance level
Step 2:

(www.variation.com)

Statistical Procedures for the
Medical Device Industry
2013/2014
www.variation.com
Step 2:

(www.variation.com)
Select BEST Sampling Plan
Compare samples sizes and AQLs to determine
best choice at a specified performance level
Attribute Plan Selection

Choose sample size by
Comparing AQL with expected
performance of process
The lower the process percent defective,
the lower the sample size (n) and accept
number (a) can be
Why is AQL important

Effects chances of passing
Effects overall cost of validation
Attribute Plan Selection

Why is AQL important
Effects chances of passing (Higher defective, need higher
AQL to pass)
Effects overall cost of validation
Example of LTPD0.05 = 1% Plans

All these plans allow the same confidence statement to be
made
They have different chances of passing (AQL)
Sampling Plan
AQL
LTPD0.05
n=300, a=0
0.017%
1.0%
n=470, a=1
0.076%
1.0%
n=630, a=2
0.13%
1.0%
n=770, a=3
0.18%
1.0%

LTPD0.05 = 1% Plans
Pa
Defective/Nonconforming Units
Single: n=300, a=0
Single: n=470, a=1
Single: n=630, a=2
Single: n=770, a=3
0.5
0
0
Percent Defective
All these plans have LTPD0.05 = 1%

Variables Plan Selection

Choose sample size by
Comparing AQL with expected performance of process.
AQL estimated from process Ppk during design verification
studies (PPU or OQ)
Example of LTPD0.05 = 1% Plans (1-Sided)

Sampling Plan
AQL
LTPD0.05
n=15, Ppk=1.17
0.00017% (Ppk=1.55)
1% (Ppk=0.78)
n=20, Ppk=1.10
0.0012% (Ppk=1.41)
1% (Ppk=0.78)
n=30, Ppk=1.02
0.008% (Ppk=1.26)
1% (Ppk=0.78)
Sample Size &

Ppk to pass plan
Process Ppk
estimate (accept
95% of time)

Ppk value
that will fail
LTPD = 1%
(Variables 1-sided 95% Confidence)
Sampling Plan
AQL
LTPD0.05
n=15, Ppk=1.17
0.00017% (Ppk=1.55)
1% (Ppk=0.78)
n=20, Ppk=1.10
0.0012% (Ppk=1.41)
1% (Ppk=0.78)
n=30, Ppk=1.02
0.008% (Ppk=1.26)
1% (Ppk=0.78)
n=40, Ppk=0.98
0.02% (Ppk=1.18)
1% (Ppk=0.78)
n=50, Ppk=0.95
0.04% (Ppk=1.12)
1% (Ppk=0.78)
n=60, Ppk=0.94
0.05% (Ppk=1.10)
1% (Ppk=0.78)
n=80, Ppk=0.91
0.09% (Ppk=1.04)
1% (Ppk=0.78)
n=100, Ppk=0.89
0.13% (Ppk=1.01)
1% (Ppk=0.78)

LTPD = 1%
(Variables 2-sided 95% Confidence)
Sampling Plan
AQL
LTPD0.05
n=15, Ppk=1.17, Pp=1.17
0.00016% (Ppk=1.55)
1% (Ppk=0.78)
n=20, Ppk=1.11, Pp=1.13
0.001% (Ppk=1.42)
1% (Ppk=0.78)
n=30, Ppk=1.03, Pp=1.07
0.007% (Ppk=1.27)
1% (Ppk=0.78)
n=40, Ppk=0.99, Pp=1.04
0.018% (Ppk=1.19)
1% (Ppk=0.78)
n=50, Ppk=0.96, Pp=1.02
0.033% (Ppk=1.13)
1% (Ppk=0.78)
n=60, Ppk=0.95, Pp=1.01
0.044% (Ppk=1.11)
1% (Ppk=0.78)
n=80, Ppk=0.92, Pp=0.99
0.08% (Ppk=1.05)
1% (Ppk=0.78)
n=100, Ppk=0. 90, Pp=0.97
0.11% (Ppk=1.02)
1% (Ppk=0.78)

Suppose:
2-sided
LTPD.05 = 1%
Have data
where
Ppk = 1.06
Sampling Plan
AQL
LTPD0.05
n=15, Ppk=1.17, Pp=1.17
0.00016% (Ppk=1.55)
1% (Ppk=0.78)
n=20, Ppk=1.11, Pp=1.13
0.001% (Ppk=1.42)
1% (Ppk=0.78)
n=30, Ppk=1.03, Pp=1.07
0.007% (Ppk=1.27)
1% (Ppk=0.78)
n=40, Ppk=0.99, Pp=1.04
0.018% (Ppk=1.19)
1% (Ppk=0.78)
n=50, Ppk=0.96, Pp=1.02
0.033% (Ppk=1.13)
1% (Ppk=0.78)
n=60, Ppk=0.95, Pp=1.01
0.044% (Ppk=1.11)
1% (Ppk=0.78)
n=80, Ppk=0.92, Pp=0.99
0.08% (Ppk=1.05)
1% (Ppk=0.78)
n=100, Ppk=0. 90, Pp=0.97
0.11% (Ppk=1.02)
1% (Ppk=0.78)
What sample size should be selected to

provide 95% of passing?
What is corresponding AQL?
Step 3:
Document Sampling Plan
and Analysis Methods in Protocol
Document in Protocol
Test method, products to be tested, and specifications
(variables or attribute data)
Worst case product(s)
Estimated process Ppk or estimated AQL

To determine sample size and acceptance criteria
Risk based selection of Performance Level (LTPD.05)

Corresponding Confidence Statement
Validation lot specifics and instructions for ensuring a

representative sample
Method of Analysis (LCR, Grouped, Sublotted, Statistical
Package)
Step 3:
Document Sampling Plan
and Analysis Methods in Protocol
Confidence Statement Examples to Meet

Validation Objectives
Per 95% Confidence Sampling Plan for LTPD.05 =
1%, the validation will pass for fill volume if the Ppk
is 1.11 or greater.
If this validation passes one can state with 95%
confidence that the process for controlling fill
volume is less than 1% defective.
Example
LTPD = 1%
Attribute Plans with 90% Confidence
Attribute Plans with 95% Confidence
Type
Parameters
AQL
LTPD0.1
Type
Parameters
AQL
LTPD0.05
Single
n=230, a=0
0.02%
1%
Single
n=300, a=0
0.02%
1%
Single
n=390, a=1
0.09%
1%
Single
n=470, a=1
0.08%
1%
Double
n1=250, a1=0, r1=2, n2=400, a2=2
0.11%
1%
Double
n1=325, a1=0, r1=2, n2=400, a2=2
0.09%
1%
Single
n=530, a=2
0.15%
1%
Single
n=630, a=2
0.13%
1%
Double
n1=250, a1=0, r1=3, n2=560, a2=3
0.18%
1%
Double
n1=325, a1=0, r1=3, n2=580, a2=3
0.15%
1%
Single
n=670, a=3
0.20%
1%
Single
n=770, a=3
0.18%
1%
Double
n1=250, a1=0, r1=3, n2=720, a2=4
0.21%
1%
Double
n1=325, a1=0, r1=3, n2=720, a2=4
0.18%
1%
Variables 1-sided 95% Confidence
Variables 2-sided 95% Confidence
Parameters
AQL
LTPD0.05
Parameters
AQL
LTPD0.05
n=15, P pk =1.17
0.00017% (Ppk =1.55)
1% (Ppk =0.78)
n=15, Ppk =1.17, Pp =1.17
0.00016% (Ppk =1.55)
1% (P pk=0.78)
n=20, P pk =1.10
0.0012% (Ppk =1.41)
1% (Ppk =0.78)
n=20, Ppk =1.11, Pp =1.13
0.001% (P pk =1.42)
1% (P pk=0.78)
n=30, P pk =1.02
0.008% (P pk =1.26)
1% (Ppk =0.78)
n=30, Ppk =1.03, Pp =1.07
0.007% (P pk =1.27)
1% (P pk=0.78)
n=40, P pk =0.98
0.02% (P pk =1.18)
1% (Ppk =0.78)
n=40, Ppk =0.99, Pp =1.04
0.018% (P pk =1.19)
1% (P pk=0.78)
n=50, P pk =0.95
0.04% (P pk =1.12)
1% (Ppk =0.78)
n=50, Ppk =0.96, Pp =1.02
0.033% (P pk =1.13)
1% (P pk=0.78)
n=60, P pk =0.94
0.05% (P pk =1.10)
1% (Ppk =0.78)
n=60, Ppk =0.95, Pp =1.01
0.044% (P pk =1.11)
1% (P pk=0.78)
n=80, P pk =0.91
0.09% (P pk =1.04)
1% (Ppk =0.78)
n=80, Ppk =0.92, Pp =0.99
0.08% (P pk =1.05)
1% (P pk=0.78)
n=100, Ppk =0.89
0.13% (P pk =1.01)
1% (Ppk =0.78)
n=100, Ppk =0. 90, Pp=0.97
0.11% (P pk =1.02)
1% (P pk=0.78)
Tables Developed from Validated Sampling Plan Analyzer Version 2.0

Copyright 2001 Taylor Enterprises Inc.
L C R
Step 4 & 5
Execute Sampling Plan given in Protocol
Document Results and Conclusion in Final Report
EXAMPLE
PQ Analysis
Process Capability Sixpack of Lot 1 Grouped
Sample M ean
Xbar Chart
Capability Histogram
UCL=1.2199
LSL
Specifications
LSL 1
1.20
_
_
X=1.1483
1.15
1.10
LCL=1.0766
1
11
13
15
17
19
1.035 1.080 1.125 1.170 1.215
Sample Range
R Chart
Normal Prob Plot
1. Is Normality an
issue with the Grouped
Data?
A D : 1.746, P : < 0.005
0.2
UCL=0.1804
0.1
_
R=0.0701
0.0
LCL=0
1
11
13
15
17
19
1.0
Within
StDev 0.04139
Cp
*
Cpk
1.19
PPM
170.42
1.15
1.10
5
10
1.1
1.2
1.3
Capability Plot
Last 20 Subgroups
1.20
V alues
LCR Grouped Analysis

In Minitab
15
20
Within
O verall
Overall
StDev 0.03836
Pp
*
Ppk
1.29
Cpm
*
PPM
55.65
Specs
Sample
2. Is Ppk for Grouped

data Ppk > 0.95?
Distribution
Analyzer at
www.variation.com
Distribution
Analyzer
PQ Analysis (Steps 4 & 5)

Xbar Chart
Sample M ean
UCL=1.1797
LSL
S pecifications
LS L 1
1.16
_
_
X=1.1235
1.12
1.08
LCL=1.0673
1
11
13
15
17
19
1.00
1.04
Sample Range
R Chart
1.08
1.12
1.16
1.20
Normal Prob Plot
1. Is Normality an
Data?
A D : 0.597, P : 0.116
0.16
UCL=0.1414
0.08
_
R=0.0549
0.00
LCL=0
1
11
13
15
17
19
1.0
Last 20 Subgroups
1.15
1.10
5
10
15
20
Sample

data Ppk > 0.95?
Distribution
Analyzer at
www.variation.com
1.1
1.2
Capability Plot
Within
StDev 0.03245
Cp
*
Cpk
1.27
PPM
70.59
1.20
V alues

In Minitab
Within
Ov erall
Specs
Overall
StDev 0.03598
Pp
*
Ppk
1.14
Cpm
*
PPM
299.16
Distribution
Analyzer
PQ Analysis (Steps 4 & 5)

Sample M ean
Xbar Chart
UCL=1.2212
LSL
1.20
S pecifications
LS L 1
_
_
X=1.1293
1.12
1.04
LCL=1.0374
1
11
13
15
17
19
1.00
1.05
1.10
Sample Range
R Chart
1.15
1.20
1.25
Normal Prob Plot

A D : 0.678, P : 0.073
UCL=0.2313
0.2
_
R=0.0898
0.1
0.0
LCL=0
1
11
13
15
17
19
1.0
Last 20 Subgroups
V alues

In Minitab
1.20
1.12
1.04
10
15
20
Sample

data Ppk > 0.95?
Investigate
Larger than
expected
Variation.
Distribution
Analyzer at
www.variation.com
1.2
1.3
Capability Plot
Within
StDev 0.05306
Cp
*
Cpk
0.81
PPM
7423.40
1.1
1. Is Normality an
Data?
W ithin
O v erall
Overall
StDev 0.05365
Pp
*
Ppk
0.80
Cpm
*
PPM
7983.88
Specs
Distribution
Analyzer
Step 5
Results: Validation Report
Data
Analysis and Conclusions
Was acceptance criteria met?
Did validation pass?
What confidence statement can be made if
criteria was met?
Step 5
Results: Validation Report Example
ABC
XYZ
Questions?
Contact Information
Jacalyn L. Schroeder 3M Company
Title: Statistician, Process Validation/Quality
Specialist
E-mail: jlschroeder2@mmm.com
Work Phone: 605-696-1355
Dr. Wayne Taylor, Taylor Enterprises

Website: www.variation.com
References
1. Dr. Wayne A. Taylor, Guide to Acceptance Sampling,
version 1, www.variation.com, Taylor Enterprises,Inc.
Note: Version 2 of new book 2013-2014.
2. GHTF/SG3/N99-10:2004 (Edition 2) , Quality
Management Systems - Process Validation Guidance,
January 2004
3. Acceptance Sampling in Quality Control, 2nd edition,
Schilling & Neubauer
4. Validation Sampling Plan Course, Wayne Taylor, March
2008
5. Acceptance Sampling and Control Class, Neubauer, 2012
6. Standards: ANSI Z1.4, ANSI Z1.9, ISO 2859-1, ISO 39511
7. Schilling/Johnson, Tables for the Construction of
Matched Single, Double, and Multiple Sampling Plans
with application to MIL-STD-105D, Journal Quality
Technology, October, 1980

Statistics in Validation

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Statistics in Validation

Uploaded by

Copyright:

Available Formats

Statistics In Validation

Sampling Plans that Result in

Strong Presence in Many Segments

HEALTH INFORMATION SYSTEMS

J.L. Schroeder , 3M, March 2014

Includes both a sample size

Basic Sampling Plan

Count the number

J.L. Schroeder, 3M, March 2014

Sampling Plan Selection

3. Determine appropriate statistical

J.L. Schroeder , 3M, March 2014

OC Curve and Two Points

J.L. Schroeder , 3M, March 2014

J.L. Schroeder , 3M, March 2014

Every Sampling Plan Has Its Own OC

Single: n=3000, a=0

J.L. Schroeder, 3M, March 2014

Determine the chances

Every Sampling Plan Has Its Own OC

J.L. Schroeder , 3M, March 2014

Sampling Plans and Risk

J.L. Schroeder, 3M, March 2014

J.L. Schroeder , 3M, March 2014

Sampling Plans to Meet

Sampling Plans for Validation

Reject = Fail validation study and

J.L. Schroeder , 3M, March 2014

Regulations and Sampling Plans

J.L. Schroeder , 3M, March 2014

The AQL (Acceptable Quality Level) of a

What is LTPD (AKA RQL)?

The LTPD (Lot Tolerance Percent Defective) of

Performance Levels [LTPD.05] for PQ

PV SOP procedure to define

95% Confidence statement

J.L. Schroeder , 3M, March 2014

Sampling Plans and

General Validation Roadmap

Validation Sampling Plans

J.L. Schroeder , 3M, March 2014

Determine Plan Protection

Performance Levels at LTPD (LTPD.05)

J.L. Schroeder , 3M, March 2014

Performance Levels at LTPD.05

Resource: Taylor Enterprises

Step 1: Determine Plan Protection

Make Confidence Statement

J.L. Schroeder , 3M, March 2014

Two Questions You Should Always Ask:

J.L. Schroeder , 3M, March 2014

This table is for attribute data, which gives larger sample

Single Sampling Plans With a=0

90% Confidence Meet

95% Confidence Meet

Select Sampling Plans

Use Validation Sampling Plan Tables

Attribute Sampling Plans

Double Sampling Plan

Take second representative

Continue To Second Stage

Resource: Dr. Wayne Taylor

n1=325, a1=0, r1=2, n2=400, a2=2

n1=325, a1=0, r1=3, n2=580, a2=3