This chapter serves to establish that the objectives for the project were met. It provides a conclusion and future implications for the project.
Conclusion
Chapter I listed four objectives that were designed to address the problem, which was to develop a validation procedure for thermoplastic injection molding processes for the medical device contract manufacturer. The four objectives were:
1. To establish what parts of and related methods for validating an injection molding process.
2. To establish a method for worse-case testing for the injection molding process.
3. To establish a procedure that describes the methods determined in objectives one and two.
4. To establish a template for documenting data collected from performing the procedure, as established in objective three.
The first and second objectives are represented by the procedure’s IOQ Template.
The template
Future Implications
Since validation is best achieved through a collaborative team effort, the planning stage may require input from manufacturing, quality, purchasing, design, and the business sectors. The validation planning stage permits each department to be engaged
early in the product development process. A validated process should yield a well defined process and identify any pitfalls of the process, further up stream verses downstream in process development.
The results of proper process validation can yield useful information and assure input early on, from all facets of the development team/manufacturing process. This aspect of validation relates to Quality Functional Deployment (QFD). QFD is a tool used to incorporate customer input into the product early on during development. For this reason, it is often referred to as the “house of quality”. Process validation has the
potential to be a quality deployment method for achieving internal customer satisfaction.
BIBLIOGRAPHY
American Society For Quality Control, American National Standard: Sampling Procedures and Tables for Inspection by Attributes, ANSI/ASQC Z1.4-1993.
American Society For Quality Control, American National Standard: Sampling Procedures and Tables for Inspection by Variables For Percent Nonconforming, ANSI/ASQC Z1.9-1993.
A Sahni and C Larsen, “Meeting FDA Process Validation Requirements,” Medical Device & Diagnostic Industry, (July 1996): 1-6.
D Allen, “FDA Wants You in Control,” Pharmaceutical and Medical Packaging News, (April 2004): 10.
D Bonanomi, “The State of Validation,” Pharmaceutical Technology, (February 2004):
98-102.
D Weese and V Buffaloe, “Conducting Process Validations with Confidence,”Medical Device & Diagnostic Industry, (January 1998): 1-12.
E Swain, “Developing A Master Plan for Complex Validation Projects,” Pharmaceutical and Medical Packaging News, (May 1999): 1-5.
Injection Molding Machine:
http://www.scudc.scu.edu/cmdoc/dg_doc/develop/process/control/b1000001.htm
J Schikora, “Qualifying High-Speed Assembly Machines as Part of Process Validation,”
Medical Device & Diagnostic Industry, (July 2000): 1-11.
JG Dickinson, “Washington Wrap-Up, On Reprocessors and Research, FDA Gently Yields,” Medical Device & Diagnostic Industry, (February 2000): 1-6.
JS Kim and JW Kalb, “Design of Experiments: An Overview and Application Example,”
Medical Device & Diagnostic Industry, (March 1996): 78-88.
N Sparrow, “Special Report: Outsourcing in the Device Industry,” European Medical Device Manufacturer 10, no. 3 (1999): 78-82.
N Squeglia, Zero Acceptance Number Sampling Plans, Fourth Edition
NJ Hermanson, “Growth of Plastics Use in Medical Devices is Spurred by Cost-Cutting,”
Modern Plastics, (November 1998): A-30.
M Anderson and P Anderson, “Design of Experiments for Process Validation,” Medical Device & Diagnostic Industry, (January 1999): 1-9.
Medical Device Quality Systems Manual: A Small Entity Compliance Guide http://www.fda.gov/cdrh/dsma/gmpman.html.
Plastics Machinery-Horizontal Injection Molding Machines- Safety Requirements for Manufacture, Care, and Use, ANSI/SPI B151.1-1997.
R Kieffer, “Procedures: Improving Their Quality,” Pharmaceutical Technology, (January 2003): 64-72.
TECH MOLD INC., “What Is A Mold? : An Introduction to Plastic Injection Molding and Injection Mold Construction,” (1993-1999): 2-1.
T Miller, “Injection Molding,” Medical Device & Diagnostic Industry, (April 1996): 2-5.
T Owens, “Enhancing Device Development through Early Supplier Involvement,”
Medical Device & Diagnostic Industry, (July 2001): 1-6.
Quality System Regulation, Code of Federal Regulations, 21CFR-Part 820 Quality Management Systems – Process Validation Guidance, GHTF/SG3/N99-10:2004(Edition 2)
W Leventon, “Innovations Remake Plastic Injection Molding,” Medical Device &
Diagnostic Industry, (November 2001): 1-9.
Cathy,
Points to consider as you clean this up, take next steps, for presentation to committee:
1. Need to make sure the indents and all other formatting issues and specifications are on target per APA and BGSU guidelines and standards—must be sure all are consistent—not bad be sure to double check all.
2. The work should be converted to be past tense throughout since you have done the work now—it is past—or will be at the point of presentation.
3. Review of literature should be driven by assuring that all elements of the work have been disclosed and pursued sufficiently—my sense is this is the case and you can be done with this. May want to use a summary statement on the tail end of the chapter to explain what was accomplished, consistent with what was initiated at the outset, and done throughout, per key headings.
4. Headings used throughout, must be per APA and BGSU guidelines/standards to identify level and type of importance assigned.
5. Chapter III, page 25, needs to be started as a fresh section.
6. Chapter III needs to present each objective and identify steps taken to address the objective. Do not explain (in chapter III) what was found for each objective or step, but simply what the steps were to address the objective.
7. At chapter IV, again state each objective, one by one, and what steps were taken to address the objective (consistent with chapter III). However, now, at each step, you should discuss what was found, how it was analyzed and so on.
8. At chapter V, similar to previous chapters III and IV, you now need to explain what can be concluded based on the objectives and steps, and each set of findings and analysis for the same—but as conclusions. These also become, then, and therefore, the recommendations for other work to follow.
9. Parts 6, 7 and 8 above, while seemingly fairly redundant, are at the core of good research—and if you will use the “threaded” logic inherent in this repetition, generally this will help to flush out what was accomplished, and why, as well as what then can be stated as legitimate findings, conclusions and recommendations.
10. Also based on points 6, 7 and 8 above, it is possible that the problem and objectives will shift somewhat as you go back and actually state what you did.
11. Consider changing the problem statement, page 7, to, “The problem for this study was to develop a validation procedure for thermoplastic injection molding
processes for medical device contract manufacturers”.
12. Consider changing first objective, page 9, to, “To establish what parts of, and related methods, are necessary for validating an injection molding process”.
13. Bibliography needs to be started as a fresh section.
I suggest you make the adjustments identified by me, and that you had already indicated in your email—or as agreed in the yellowed areas of your text, and get it finalized for presentation—and let me see the final draft before you give others a copy.
JWS, 2-26-05