Statistical Procedures for the Medical Device Industry

$295.00 – $325.00

This book provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. This includes the following applications:

Statistical Policy
Process Validation
Design Verification
Component/Material Qualifications
Design Validation
Audits and Effectiveness Checks
Test Method Validation
Manufacturing Acceptance Sampling Plans and Inspections
Trending Data
Setting Specifications

The book is intended for a single user. While it can be loaned to someone, it should not be given to multiple individuals at the same time. The pdf includes the name and email of the owner on each page.

Company Licenses to the procedures are also available.

Book Format

Clear

ISBN 978-0-9635122-9-1, 8.5 x 11, 592 pages By: Dr. Wayne A. Taylor Provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. These regulatory requirements can be found in:

Code of Federal Regulation 21CFR, Part 820 Quality System Regulations
ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes

This book is designed for engineers and scientists in the medical device industry. However, it is also useful for any engineer or scientists involved in product design, process development or manufacturing.

Aids and References:

Tables: The procedures include extensive tables of sampling plans for both validation and manufacturing. Spreadsheets: On the spreadsheet tab. Technical Briefs: While the procedures provide rationales and justifications supporting the recommended approaches. They also reference the following technical briefs:

Books: Further details about the statistical techniques covered by the procedures are available in the following books:

Guide to Validation Sampling Plans covers STAT-03 to 07 and STAT-12 to 17. It is expected in 2019. Meanwhile, see the courses Validation Sampling Plans and Validation Sampling Plans II.
Guide to Acceptance Sampling covers STAT-09.
Guide to Normality Testing and Transformations covers STAT-18. It is expected in 2019. Meanwhile, see the Distribution Analyzer User Manual and course Normality and Transformations.
Guide to Trending Data covers STAT-10. It is expected in 2020. Meanwhile, see the course Trending of Quality Data.
Robust Tolerance Analysis covers STAT-11. It is expected in 2020. Meanwhile, see the VarTran User Manual and course Robust Tolerance Analysis.
Optimization & Variation Reduction in Quality covers STAT-10 and STAT-11.

Courses: Training on all the procedures is available.

Policy and General: STAT-01 is the general policy procedure and STAT-02 provides definitions used by the procedures.

STAT-01 Statistical Policy STAT-02 Glossary of Statistical Terms

Areas of Application: STAT-03 to STAT-11 describe the statistical requirements for each area of application. They may also provide statistical techniques that are specific to that area of application or reference a supporting statistical technique procedure.

STAT-03 Statistical Techniques for Process Validation STAT-04 Statistical Techniques for Design Verification STAT-05 Statistical Techniques for Component/Material Qualifications STAT-06 Statistical Techniques for Design Validation STAT-07 Statistical Techniques for Audits and Effectiveness Checks STAT-08 Statistical Techniques for Test Method Validation STAT-09 Manufacturing Acceptance Sampling Plans and Inspections STAT-10 Statistical Techniques for Trending Data STAT-11 Statistical Techniques for Setting Specifications

Supporting Statistical Techniques: STAT-12 to STAT-19 describe specific statistical techniques. They do not specify any additional requirements beyond those in the policy and application procedures.

STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities STAT-14 Verification/Validation Sampling Plans for Average STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD STAT-16 Statistical Techniques for Equivalence Testing STAT-17 Statistical Techniques for Reliability Life Testing STAT-18 Statistical Techniques for Normality Testing and Transformations STAT-19 Rounding of Data

Training on the Procedures

Procedure	Training
STAT-01 Statistical Policy	Presentation on Ensuring Sound Statistical Practices (2 hour)
STAT-02 Glossary of Statistical Terms	Relevant terms covered in individual courses
STAT-03 Statistical Techniques for Process Validation	Validation Sampling Plans (1 day)
STAT-04 Statistical Techniques for Design Verification	Validation Sampling Plans (1 day)
STAT-05 Statistical Techniques for Component/Material Qualifications	Validation Sampling Plans (1 day)
STAT-06 Statistical Techniques for Design Validation	Can be included in Validation Sampling Plans (1 day)
STAT-07 Statistical Techniques for Audits and Effectiveness Checks	Presentation on Effectiveness Checks (3 hour)
STAT-08 Statistical Techniques for Test Method Validation	Statistical Techniques for Test Method Validation (1 day)
STAT-09 Manufacturing Acceptance Sampling Plans and Inspections	Successful Acceptance Sampling (Manufacturing Focused - 1 day)
STAT-10 Statistical Techniques for Trending Data	Trending of Quality Data (1 day)
STAT-11 Statistical Techniques for Setting Specifications	Robust Tolerance Analysis (2 day) First day covers basics Design of Experiments I - Screening Experiments (1 day)
STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming	Validation Sampling Plans (1 day)
STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities	Validation Sampling Plans II (1 day) First half of day
STAT-14 Verification/Validation Sampling Plans for Average	Validation Sampling Plans II (1 day) First half of day
STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD	Validation Sampling Plans II (1 day) First half of day
STAT-16 Statistical Techniques for Equivalence Testing	Validation Sampling Plans II (1 day) Second half of day
STAT-17 Statistical Techniques for Reliability Life Testing
STAT-18 Statistical Techniques for Normality Testing and Transformations	Normality Testing and Transformations (1/2 day)
STAT-19 Rounding of Data

This book includes step-by-step instruction for executing the 43 statistical techniques included below. For many of the procedures validated spreadsheets are provided. For selecting sampling plans, extensive tables are provided. Otherwise, instructions are provided for executing the procedure in Minitab, Distribution Analyzer, Change-Point Analyzer, Sampling Plan Analyzer and VarTran® software packages.

Area/Statistical Technique	Where to Find
Confidence Intervals – 1 Group
Upper Confidence Limit for Percent Conforming – Attribute Data	STAT-12, Appendix D
Upper Confidence Limit for Percent Conforming – Variables Data	STAT-12, Appendix E
Upper Confidence Limit for Rate of Nonconformities	STAT-13, Appendix D
Confidence Limits for the Average	STAT-14, Appendix A
Upper Confidence Limit for Standard Deviations	STAT-15, Appendix I
Upper Confidence Limit for Relative Standard Deviations	STAT-15, Appendix J
Confidence Intervals – 2 Groups
Confidence Limits for the Difference between Two Averages	STAT-16, Appendix A
Confidence Limits for the Difference between Two Averages – Paired Data	STAT-16, Appendix C
Confidence Limits for the Ratio of Two Standard Deviations	STAT-16, Appendix D
Equivalence Tests
Equivalence Test for the Average	STAT-14, Appendix B
Equivalence Test for Two Averages	STAT-16, Appendix B
Equivalence Test for Two Averages – Paired Data	STAT-16, Appendix D
Equivalence Test for Two Standard Deviations	STAT-16, Appendix F
General Techniques
Regression Analysis – Correlation Study for Substitute Measurement Methods	STAT-08, Appendix I
Analysis of Variance (ANOVA)	STAT-18, Appendix E
Kruskal-Wallis Test	STAT-18, Appendix F
Capability Study	STAT-11, Appendix F
Screening Experiment – Design of Experiment	STAT-11, Appendix D
Response Surface Study – Design of Experiments	STAT-11, Appendix E
Normality Test
General Normality Tests (Anderson-Darling, Shapiro-Wilk and Skewness-Kurtosis All)	STAT-18, Appendix A
Skewness-Kurtosis Specific Normality Test	STAT-18, Appendix C
Sampling Plans (Also see Equivalence Tests)
Attribute Single and Double Sampling Plans for Proportion Nonconforming	STAT-07, Appendix A STAT-09, Appendix A STAT-12, Appendix A
Variables Single and Double Sampling Plans for Proportion Nonconforming	STAT-09, Appendix A STAT-12, Appendix B
Narrow Limit Gauging Single and Double Sampling Plans for Proportion Nonconforming	STAT-09, Appendix A
Single and Double Sampling Plans for Rate of Nonconformities	STAT-07, Appendix B STAT-13, Appendix A
Single and Double Sampling Plans for Standard Deviations	STAT-15, Appendix A
Single and Double Sampling Plans for Relative Standard Deviations	STAT-15, Appendix B
Product Life Sampling Plans – Parametric with Specified Test Time	STAT-17, Appendix A
Product Life Sampling Plans – Censored Failure Time Plans	STAT-17, Appendix B
Specification Setting
Tolerance Analysis	STAT-11, Appendix A
Tolerance Sensitivity Analysis	STAT-11, Appendix B
Robust Design using Tolerance Analysis	STAT-11, Appendix C
Test Method Validations
Gauge R&R Study	STAT-08, Appendix B
Gauge Reproducibility Study (Variance Components Analysis)	STAT-08, Appendix C
Trending Tools
Pareto Chart	STAT-10, Appendix A
or Average-Standard Deviation Control Chart	STAT-10, Appendix B
Normalized I_N Chart for Individual Values	STAT-10, Appendix C
Box-Cox I Chart	STAT-10, Appendix D
U Chart for Counts with Independent Events	STAT-10, Appendix E
P Chart for Pass/Fail Proportions with Independent Events	STAT-10, Appendix F
Laney U’ Chart for Counts with Dependent Events	STAT-10, Appendix G
Laney P’ Chart for Pass/Fail Proportions with Dependent Events	STAT-10, Appendix H
Change-Point Analysis	STAT-10, Appendix I

The spreadsheets below are provided as part of purchasing or licensing the book Statistical Procedures for the Medical Device Industry. Permission is granted to purchasers of the book to use and modify the spreadsheets for their personal use. Permission is granted to companies licensing one of the procedures in the title of the Excel file to use and modify the spreadsheet for use within the company per the book's licensing agreement. There are two versions of each spreadsheet. The first is protected. Only cells required to enter data and select options can be altered. This is the version used for the validation as this ensures the formulas cannot be changed. However, tabs can be deleted and copied to customize the layout of the spreadsheet. The second version is unprotected. This allows access to the formulas and allows the spreadsheets to be customized. The protected versions have been validated as required in the medical device industry. The validation package can also be downloaded below.

STAT-10 - Control Charts.xlsx

Download STAT-10 - Control Charts - Protected

Download STAT-10 - Control Charts - Unprotected

Download STAT-10 - Control Charts - Validation Report PDF

STAT-12 to 16 - Confidence Intervals and Equivalence Tests.xlsx

Download STAT-12 to 16 - Confidence Intervals and Equivalence Tests - Protected

Download STAT-12 to 16 - Confidence Intervals and Equivalence Tests - Unprotected

Download STAT-12 to 16 - Confidence Intervals and Equivalence Tests - Validation PDF

STAT-18 - Skewness Kurtosis Normality Tests.xlsx

Download STAT-18 - Skewness Kurtosis Normality Tests - Protected

Download STAT-18 - Skewness Kurtosis Normality Tests - Unprotected

Download STAT-18 - Skewness Kurtosis Normality Tests - Validation Report PDF

Changes in Second Printing from First Printing

STAT-09 Manufacturing Acceptance Sampling Plans and Inspections

Table 3 on page 140, changed as follows:

- For Moderate Process Risk:
  - - From: RQL up to 12 times the AQL (Appendix A: L-5 to L-13)
    - To: RQL up to 9 times the AQL (Appendix A: L-6 to L-13)

- For Low Process Risk:
  - - From: RQL up to 45 times the AQL (Appendix A: L-1 to L-13)
    - To: RQL up to 16 times the AQL (Appendix A: L-4 to L-13)

This change results in better aligning STAT-08 with ANSI Z1.4 and ISO 2859-1. For an AQL of 1.0%, Z1.4 has the plans 13/(0,1), 50/(1,2), 80/(2,3), 125/(3,4), 200/(5,6), … With this change low process risk is 13/(0,1), moderate process risk is 50/(1,2) and high process risk is 125/(3,4).

Previously, low process risk was 5/(0,1) with an RQL of 36.9. Some consider this too little protection. Designers of Z1.4 wrestled with whether to fix the probability of acceptance at the AQL at 95% or let it vary. 5/(0,1) has an AQL of 1.0, while 13/(0,1) has an AQL of 0.4%. They let it vary going with the plan 13/(0,1). While my tables fix the probability of acceptance at the AQL at 95%, this change has the same effect of avoiding the 5/(0,1) plan.

Consider this change as a suggestion that may be appropriate for some but not all readers.

Errata for both Second and First Printing

Multiple occurrences of the word gage should be replaced with gauge.

STAT-02 Glossary of Statistical Terms

Page 24, under definition for Distribution function, "average of 7" should be "average of 10."

STAT-03 Statistical Techniques for Process Validation

Pages 35, 38 and 48, "OC characterization" should be "OQ characterization"

STAT-06 Statistical Techniques for Design Validation

Page 78, two occurrences of nonconforming should be conforming.

STAT-08 Statistical Techniques for Test Method Validation

Page 119, the guardband equations are in error and should read as shown below.

Lower guardband limit = LSL + Max_bias + K x UCL_σ-guardband Upper guardband limit = USL + Min_bias – K x UCL_σ-guardband

STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming

Page 360, for 95/90 Variables—One-Sided Specification the P_pk acceptance criterion for n=15 can be reduced from 0.70 to 0.69.

STAT-18 Statistical Techniques for Normality Testing and Transformations

Page 570, Section 6.1 should say: "For a single normality test, the test is considered to pass if the p-value is > 0.05."

On pages 564 and 565, log functions should all be interpreted as natural logs. Any time in the book log is mentioned, it refers to the natural log. However, when transforming data, it does not matter whether natural logs or log10 is used.

Errata for First Printing Corrected in Second Printing

They have been corrected in the current second printing.

Table of Content and elsewhere

STAT-10 title has "tending" rather than "trending".

Introduction

Table 1 of page 3. RNP should be RPN.

STAT-02 Glossary

Page 25, kurtosis, as defined here, is sometimes referred to as the excess kurtosis and is the statistical kurtosis minus 3.

STAT-08 Statistical Techniques for Test Method Validation

Page 101, the reference in Section 6.3.2 to Section 6.3 should be a reference to Section 6.3.1.

STAT-09 Manufacturing Acceptance Sampling Plans and Inspections

Page 142, Example box should give n=80, a=2 as the "also use" sampling plan rather than n=80, a=3.

Page 162, the AQL=10%, L-3, Variables Single, σ unknown plan is in error. Change MSD to 333.3%.

Page 173 the AQL=1%, L-8, Variables Single, σ unknown plan is in error. Change MSD to 22.5%.

STAT-10 Statistical Techniques for Trending

Page 200, the last sentence should reference Appendix I and not Appendix J.

Page 214 the equations for the control limit should be as shown below.

Page 233 the equations for the control limits of the I_N chart should be as shown below.

Page 247, bottom right, 0.000502 should be 0.000557.

STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities

Page 424 makes reference to the Beta distribution. It should have referenced the Gamma distribution. There are also some formatting issues.

STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD

Page 471 shows screenshots for 95% confidence rather than the 90% confidence stated in the text. The confidence statements given in the text are correct but do not align with the graphic.

Page 472 shows formulas for the confidence intervals for the standard deviation. These formulas use the CHIINV function in Excel, which returns the inverse of the right-tailed chi-squared distribution function. These are the formulas used in the spreadsheet. For the more common inverse of the left-tailed chi-squared distribution function, reverse the formulas for the upper and lower confidence limits.

STAT-17 Statistical Techniques for Reliability Life Testing

Page 530, the last two paragraphs of the example should read:

To select a plan, use Appendix B of STAT-13. The ratio RQL/AQL = 4. The resulting single sampling plan is n = 11.8424/RQL, a = 6. Plugging 2 in for the RQL results in n = 5.9212. This can be rounded up to n = 6 years.

It is desired to complete the testing within 6 months. This requires testing 12 pumps for half a year to produce 6 years of test time. If 6 or fewer service events occur, the sampling plan passes, and it can be stated with 95% confidence that the rate of service events is below 2 per year.

Page 531, the same changes should be made to the last two paragraphs of the example.

STAT-18 Statistical Techniques for Normality Test and Transformations

Page 565 if states Z_k is valid for n≥20. Simulations demonstrate it is valid for n≥15.