Application of design of experiment (DOE) techniques to process validation in medical device manufacture

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Abstract

Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U.S. Food and Drug Administration (FDA) Quality System Regulations (QSR) 820 Part 21 Code of Federal Regulations (CFR) “Quality Systems for Medical Devices,” require process validation as a regulatory requirement. Design of experiment (DOE) statistical methods will allow these requirements to be met in the most resource-efficient manner possible, whilst providing a greater understanding of the process and highlighting opportunities for quality improvement.This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance.
LanguageEnglish
Pages92-100
JournalJournal of Validation Technology
Volume12
Issue number2
Publication statusPublished - Feb 2006

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Design of experiments
Aerospace industry
Automotive industry
Standardization
Statistical methods
Industry

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@article{3bedcedf58254aa98e499c3040bf0367,
title = "Application of design of experiment (DOE) techniques to process validation in medical device manufacture",
abstract = "Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U.S. Food and Drug Administration (FDA) Quality System Regulations (QSR) 820 Part 21 Code of Federal Regulations (CFR) “Quality Systems for Medical Devices,” require process validation as a regulatory requirement. Design of experiment (DOE) statistical methods will allow these requirements to be met in the most resource-efficient manner possible, whilst providing a greater understanding of the process and highlighting opportunities for quality improvement.This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance.",
author = "D Dixon and J Eatock and BJ Meenan and M Morgan",
note = "Reference text: 1. Johnston R., 1995, “Validation Proof or Document Elegance,” Medical Device and Diagnostic Industry, Vol. 17, Part 6, pp. 20-22. 2. Booker J.D., 2003, “Industrial Practice in Designing for Quality,” International Journal of Quality Reliability and Management, Vol. 20, No. 3, pp. 388-203. 3. Pande, P.S, Mewman, R.P. and Cavanagh, R.R., 2000, The Six Sigma Way, (McGraw Hill, ISBN 0-07-135806-4). 4. Coronado, R.B. and Antony, J, 2002, “Critical Success Factors for the Implementation of Six Sigma Projects,” The TQM Magazine, Vol. 14, No. 2, pp. 92-99. 5. Mark, J. et al, 1999, “Design of Experiment for Process Validation,” Medical Device and Diagnostic Industry, Vol. 21, pp. 193-199. 6. Anthony J, 2000, “Improving the Manufacturing Process Quality and Capability Using Experimental Design: A Case Study,” International Journal of Production Research, Vol. 38, No 12, pp. 2607-2618. 7. Reddy RBS and Babu A.S. 1998, “Taguchi Methodology for Multi Response Optimisation,” International Journal of Quality Reliability and Management, Vol. 15, pp.646-668. 8. Montgomery, D.C., 1996, Introduction to Statistical Quality Control, 3rd Edition, (New York: John Wiley & Son), p. 478. 9. Good Manufacturing Procedures, U.S. Food and Drug Administration, Process Validation, Section-820, Part 4. 10.Quality Management Systems, Process Validation Requirements, Jan. 2004, Edition 2, Global Harmonization Task Force. 11. Guidance on the General Principles of Process Validation, May 1987, Guidance Document, FDA Centre for Devices and Radiological Health. 12. Weese, D. L., 1998, “Conducting Process Validations with Confidence,” Medical Device and Diagnostic Industry, Vol. 20, pp. 107-112. 13. Alexander, K., 2000, “Good Design Practice for Medical Devices and Equipment,” Journal of Medical Engineering and Technology, Vol. 24, No. 1, pp. 5-13. 14. Dixon, D. et al, 2002, “The Effect of Sealing Properties on the Fracture Mechanism and Peel Properties of Medical Packaging Materials,” Journal of Applied Medical Polymers, Vol. 6, No 1, pp. 30-34. 15. Barcan D., 1995, “Using a Seal Matrix to Optimise Package Sealing Variables,” Medical Device and Diagnostic Industry, Vol. 17, No. 9, pp. 112-122. 16. Kim. J.S. and Kalb. J.W., 1996, “Design of Experiment, an Overview and Application Example,” Medical Device and Diagnostic Industry, Vol. 18, Part 3, pp. 78-88. 17. Montgomery. D.C., 1997, Design and Analysis of Experiments, (New York: John Wiley & Son, ISBN 0-471-15746-5), pp. 41-48.",
year = "2006",
month = "2",
language = "English",
volume = "12",
pages = "92--100",
journal = "Journal of Validation Technology",
issn = "1079-6630",
number = "2",

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N1 - Reference text: 1. Johnston R., 1995, “Validation Proof or Document Elegance,” Medical Device and Diagnostic Industry, Vol. 17, Part 6, pp. 20-22. 2. Booker J.D., 2003, “Industrial Practice in Designing for Quality,” International Journal of Quality Reliability and Management, Vol. 20, No. 3, pp. 388-203. 3. Pande, P.S, Mewman, R.P. and Cavanagh, R.R., 2000, The Six Sigma Way, (McGraw Hill, ISBN 0-07-135806-4). 4. Coronado, R.B. and Antony, J, 2002, “Critical Success Factors for the Implementation of Six Sigma Projects,” The TQM Magazine, Vol. 14, No. 2, pp. 92-99. 5. Mark, J. et al, 1999, “Design of Experiment for Process Validation,” Medical Device and Diagnostic Industry, Vol. 21, pp. 193-199. 6. Anthony J, 2000, “Improving the Manufacturing Process Quality and Capability Using Experimental Design: A Case Study,” International Journal of Production Research, Vol. 38, No 12, pp. 2607-2618. 7. Reddy RBS and Babu A.S. 1998, “Taguchi Methodology for Multi Response Optimisation,” International Journal of Quality Reliability and Management, Vol. 15, pp.646-668. 8. Montgomery, D.C., 1996, Introduction to Statistical Quality Control, 3rd Edition, (New York: John Wiley & Son), p. 478. 9. Good Manufacturing Procedures, U.S. Food and Drug Administration, Process Validation, Section-820, Part 4. 10.Quality Management Systems, Process Validation Requirements, Jan. 2004, Edition 2, Global Harmonization Task Force. 11. Guidance on the General Principles of Process Validation, May 1987, Guidance Document, FDA Centre for Devices and Radiological Health. 12. Weese, D. L., 1998, “Conducting Process Validations with Confidence,” Medical Device and Diagnostic Industry, Vol. 20, pp. 107-112. 13. Alexander, K., 2000, “Good Design Practice for Medical Devices and Equipment,” Journal of Medical Engineering and Technology, Vol. 24, No. 1, pp. 5-13. 14. Dixon, D. et al, 2002, “The Effect of Sealing Properties on the Fracture Mechanism and Peel Properties of Medical Packaging Materials,” Journal of Applied Medical Polymers, Vol. 6, No 1, pp. 30-34. 15. Barcan D., 1995, “Using a Seal Matrix to Optimise Package Sealing Variables,” Medical Device and Diagnostic Industry, Vol. 17, No. 9, pp. 112-122. 16. Kim. J.S. and Kalb. J.W., 1996, “Design of Experiment, an Overview and Application Example,” Medical Device and Diagnostic Industry, Vol. 18, Part 3, pp. 78-88. 17. Montgomery. D.C., 1997, Design and Analysis of Experiments, (New York: John Wiley & Son, ISBN 0-471-15746-5), pp. 41-48.

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N2 - Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U.S. Food and Drug Administration (FDA) Quality System Regulations (QSR) 820 Part 21 Code of Federal Regulations (CFR) “Quality Systems for Medical Devices,” require process validation as a regulatory requirement. Design of experiment (DOE) statistical methods will allow these requirements to be met in the most resource-efficient manner possible, whilst providing a greater understanding of the process and highlighting opportunities for quality improvement.This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance.

AB - Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U.S. Food and Drug Administration (FDA) Quality System Regulations (QSR) 820 Part 21 Code of Federal Regulations (CFR) “Quality Systems for Medical Devices,” require process validation as a regulatory requirement. Design of experiment (DOE) statistical methods will allow these requirements to be met in the most resource-efficient manner possible, whilst providing a greater understanding of the process and highlighting opportunities for quality improvement.This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance.

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VL - 12

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EP - 100

JO - Journal of Validation Technology

T2 - Journal of Validation Technology

JF - Journal of Validation Technology

SN - 1079-6630

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