ASQ-LA Quality News
February 2013
In This Issue
February 13th Member Meeting
Message from the Chair
CSUDH Class Listing
MSQA Term Paper
Certification Exam Dates
ASQLA Leadership Team Listing


Welcome to the February Issue of the ASQ-LA Newsletter.

Looking forward to see you at our February 13th Member Meeting @ Phenomenex 2341 West 205th Street  Torrance, CA 90501. If you plan to attend the meeting, YOU MUST RSVP to Chen Low 310-334-7044, pager 310-353-8293 or e-mail [email protected], no-later-than Noon on Monday, February 11th, so he can get the list of attendees.

Do not go to the Phenomenex main entrance on 411 Madrid. The Meeting will be on the 2nd floor of 2341 West 205th Street. Near Crenshaw and 190th. 

Looking forward to your attendance at this month's program.
Harold Martinez
Newsletter Chair


ASQLA MEMBER MEETING - February 13, 2012

 James L Hardeman, MD

"Quality of Life" 

Please join the ASQLA Section 0700 for its monthly member meeting on Wednesday, February 13th. The meeting will be at Phenomenex, 2341 West 205th Street in Torrance.  This meeting is an opportunity to network with other Quality professionals and to learn about current techniques & technologies. Our guest speaker this month is James L Hardeman, MD speaking on "Quality of Life" and presenting his book entitled Appears Younger than Stated Age.


The title of his debut book is actual medical terminology that doctors use in a patient's chart to describe that occasional person who looks good for his or her age. These patients often share many of the same characteristics and lifestyles. Over many decades and thousands of patient interviews and examinations, Dr. Hardeman describes these traits and has developed numerous strategies and recommendations for sustaining good health and a youthful appearance. He applies these methods personally, in patient care, and through his debut book. His ultimate goal is to get people to improve the QUALITY of their life. He will be highlighting how to achieve better quality by presenting his approach to looking and feeling younger, healthier and more vital. In clear everyday language, he will discuss:


  • Dietary strategies to preserve the balance of the all-important intake and output  of calories.
  • Fitness habits that will increase your lifespan.
  • Ways to keep from developing degenerative disease that so often lead to the vicious cycle of weight gain, inactivity, and deterioration of health.
  • Simple tips and methods to maintain your ideal body weight.

Dr. James L. Hardeman has been a practicing physician for 30 years. Triple board certified in Internal Medicine, Pulmonary Diseases, and Critical Care Medicine, Dr. Hardeman has maintained the demanding schedule of both hospital-based medicine and a busy office practice. After graduating Summa Cum Laude from University of California at Irvine he attended Baylor College of Medicine where he graduated with honors. Postgraduate training in Internal Medicine and Pulmonary/Critical Care Medicine took place at USC and UCI.  The recipient of numerous awards for patient care, Dr. Hardeman is Physician Adviser to the Clinical Nutrition Services at St. Jude Medical Center in Fullerton, California.


The program will be held at 2nd Floor Main Conference Room at Phenomenex 2341 West 205th Street Torrance, CA 90501. This meeting is an opportunity to network with other Quality Professionals, learn about quality related topics and earn 0.3 Recertification Units. Registration and networking starts at 5:30 PM. The meeting runs from 6:00 to 7:30 PM. Crackers, Cookies, Coffee & Water will be provided at no charge. Dr. Hardeman will be signing his book Appears Younger than Stated Age during the meeting. The book is available to our members that evening for $15.00 and is also available for purchase at


You MUST RSVP to Chen Low 310-334-7044, pager 310-353-8293 or e-mail [email protected], no-later-than Noon on Monday, Febraury11th, so he can get the list of attendees.



Message from the Chair - Lane Parrott


How are your New Years Resolutions doing? Well if you want to improve the quality of your life, improve your marketability, be acknowledged for your accomplishments or meet new people, keep reading!


QUALITY OF LIFE - Come to the February 13th ASQ LA Meeting at Phenomenex, in Torrance, to listen to Dr. Jim Hardeman's presentation: Quality of Life. He will share his secrets in the art of staying young. We will have copies of his book, Appears Younger than Stated Age, available for sale at the meeting and we will raffle several autographed copies.


IMPROVE YOUR MARKETABILITY - And get more from your weekends. Get an ASQ Certification to put on your Resume, post on LinkedIn or hang on your wall. Dr. Catherine Martin, myself and other esteemed members will teach the following ASQ Certification Prep Classes on Saturday mornings: 

  • CQA - April 13 through May 18, 2013
  • CMQ/OE - August 10 through September 28, 2013
  • CQE - August 10 through September 28, 2013
  • Green Belt - October 19 through November 23, 2013
  • Black Belt - January 11 through February 22, 2014

BE ACKNOWLEDGED FOR YOUR ACCOMPLISHMENTS - If you have three (3) or more current ASQ Certifications and you attend our November Meeting, you will be awarded a Certificate of Achievement, an ASQLA coffee mug and a gift card.


Attend 8 or more ASQLA Meetings during 2013 and receive an ASQ coffee mug at our January 15, 2014.


MEET NEW PEOPLE - Join the section's Leadership Team. We are looking for enthusiastic and dependable members who can help us provide a great experience for your members. If you are interested, please send me an Email at 

[email protected] or call 310-489-9018



 For information on placing an ad through ASQLA, contact Advertising Chair at (310)383-2393, [email protected].
California State University, Dominguez Hills



Spring 2013

First Day                       Last Day                                   Last Day

                                                  of Class                      To Register                                of Class

                                                   Mar. 20                         Mar. 16*                                      May 8


Course                                 Title                                                            Instructor

NBQA 702.41       Certified Quality Engineer Exam Prep.    Catherine French ([email protected])

CN: 22089(Non-Credit)

NBQA 703.41       Certified Quality Auditor Exam Prep.      Milton Krivokuca ([email protected])

CN: 22090(Non-Credit)

NBQA 701, 702, 703, 704, and 705 course fees are $350.00 per course.


                                               First Day                        Last Day                                Last Day

                                               of Class                        To Register                            of Class

                                                Mar. 15                          Mar. 11                                    May 10


Course                                 Title                                                             Instructor

NBQA 709.41        Certified Calibration Technician               Milt Krivokuca ([email protected])

                                Engineer Exam Prep.


                                           First Day                           Last Day                               Last Day

                                            of Class                          To Register                             of Class

                                             Mar. 20                            Mar. 16                                 Jun 26

Course Title Instructor

NBQA 710.41         Pharmaceutical GMP                          Bhavan (Bob) Mehta ([email protected])

                                 Certified Exam Prep.


NBQA 709/710 course fee is $475.00 per course.

To enroll contact the Extended Education Registration office, please call (310) 243-3741, fax (310) 516-3971, or by email at [email protected].


You Can Pay Me Now or Pay Me Later

Loran J. Paprocki

QAS 511

William Trappen




Thesis statement:



In the medical device industry, the cost of a single quality failure can eclipse the cost of a quality program.



The medical device industry is a high-stakes game. The risks are ominous in the possibility of financial loss due to products that are unsuccessful, or worse; products that fail in their function. Medical devices which are unable to meet their clinical requirements may result in harm, injury or even death to patients. The costs of entry to the market are proportionately enormous in terms of the required time, talent and treasure to bring a product to market and to generate a return on investment. In light of the dire nature of medical device failure, regulatory agencies such as the U.S. Food and Drug Administration (FDA), Health Canada and British Standards Institution provide guidance to ensuring the rigor of the quality of medical devices. While the regulatory guidance can be a valuable tool in ensuring that customer requirements are actualized by the finished device, the efforts of companies developing devices are typically slowed by those requirements. Companies who fail to invest resources to the execution of design quality systems take on the risk of negative impacts to revenue and to the lives of patients.



An early and notable example of the costs associated with ineffective quality systems is the failure of the Dalkon Shield. The Dalkon Shield was an intrauterine birth control device (IUD) whose location and reclamation was facilitated by an attached string. The manufacturer ignored internal concerns that the string might wick body fluids and lead to bacterial infections. The manufacturer, A. H. Robbins Company, had no internal experience with obstetrics or gynecology and relied upon the inventor of the device for their clinical input. A. H. Robbins' decision to disregard the infection concerns and to continue marketing the device was influenced by the early market success of the product as sales in the first year were in excess of one million units (Kastetter, 1999). The financial success was erased as the predicted wicking issue became reality; resulting in infections, septic abortions and death. Waves of resulting litigation included including a $7,500,000 punitive damage award for one of the cases (Kastetter, 1999).


While the Dalkon Shield litigation occurred in the early 1970's, the tough lessons have been repeated in more recent years. The error of placing short term financial gain over product quality impacted the design of hip replacements, with similar monetary consequences.


Stephens, D'Urso and Holmes (2006) tell the tragic story of Sulzer Orthopedics. Sulzer Orthopedics was the fourth-largest supplier of orthopedic implants. A year after the product launch of their hip replacement implants, complaint rates increased unexpectedly. North American Science Associates (NAMSA) performed analysis to detect possible causes for the complaints and discovered an oily residue on the hip joints. The residue could cause the impedance of the ingrowth of bone which was essential to a positive clinical outcome. The contamination issue was relayed to Sulzer Orthopedics who waited three weeks before announcing a voluntary product recall. A notification of the FDA followed three days later. The recall included around 40,000 units with an additional impact as similar contamination was found on their knee replacement implants. The subsequent recall affected 1,500 patients requiring the replacement of defective knee implants in 560 individuals.


Stephens et al. continue, noting the effects upon the patients that used Sulzer Orthopedics' products. Pain when moving, pain when seated for periods of time, inability to walk without the assistance of a cane, separation of the implant from the bone and lost wages were among their issues endured by the patients. Due to the time lag between the awareness of the issue and the isolation of product, at least one patient had a first problematic implant replaced with a second contaminated implant; requiring an eventual third operation. Lawsuits followed. Sulzer Orthopedics' first settlement offer was $750 million to all affected parties. Two weeks later, the conclusion of the first court case resulted in the awarding of more than $15 million dollars to three women. A few days later, Sulzer Orthopedics revised its initial settlement offer to reach $1 billion. The final settlement totaled $1.035 billion and was deposited into a trust fund just three years after the product launch.


History has repeated itself as Johnson & Johnson is currently in the courts over the performance of their hip replacement implants. Learning from Sulzer Orthopedics' lesson in the cost of litigation; Johnson & Johnson has increased its reserves for product-liability costs to $570 million in 2010 and has ear marked an additional $280 million for the potential medical costs of the recipients of Johnson & Johnson implants.  The final cost of the design failure is expected to exceed $1 billion. (Rockoff & Searcey, 2011)


To return to the initiating event at Sulzer Orthopedics; the years of legal proceedings, the billion dollar settlement, untold lawyer's fees, lost business and crippling patient pain were all due to an oily contamination on the implants. Brown University (2007) notes that the contamination was created when Sulzer Orthopedics brought portions of the product manufacturing in-house. In an effort to cut costs, a change was made to the machining oils. The materials change resulted in the residue first detected by NAMSA. In reading the FDA's design control guidance below, the warning has been carried forward by regulatory bodies.


The later in the development cycle that the change occurs, the more important the validation review becomes. There are numerous cases when seemingly innocuous design changes made late in the design phase or following release of the design to market have had disastrous consequences. (FDA Center for Devices and Radiological Health, 1997, p. 41)


It is important to note that the previous examples of catastrophic device failures were not due to failures in manufacturing but failures in the creation or maintenance of the device design. Failures were designed in rather than built in to the device. Inadequate knowledge of the customers was apparent and insufficient consideration of design changes existed. Rather than increase the core knowledge of those areas the companies moved forward with the existing design. This horrific history led to the increased regulation of medical device design. The increased regulation has been a two-edged sword as it provides guidance for the proper assessment of design but it also creates a costly burden upon the entire industry as companies work to comply with voluminous requirements. To avoid the expenses involved in developing new products required to conform to higher levels of scrutiny, a majority of new products are created under the less stringent 510(k) clearance process.


The FDA regulates the medical device industry and may approve the sale of a medical device based upon its similarity to a device that was on the market prior to the existing regulation. These devices are commonly termed 510(k) devices as connection to the pertinent section of the Food, Drug and Cosmetic Act. Wizemann (2011) notes that while manufacturing issues account for 28.5% of 510(k) device recalls, device design issues account for 28.4% of the recalls. The high percentage of device failure due to design is alarming due in part to the fact that while manufacturing issues are typically transient, design issues are persistent. Where inadequate training of an assembler may cause the manufacture of a lot of defective product, an error in the device design will exist in every device that is produced and would not be stopped by end-of-the-line quality inspections.


Among design issues, Ward and Clarkson (2004) note that the main cause of device failure is user error. It is important to note that user error is not defined as simply being a mistake by a user. Rather, the concept includes that some mistakes by the user should be expected and avoided by the design of the product. If a user was instructed to cut the blue wire with the red stripe, but instead cut the red wire with a blue stripe, the effect is a user error due to the manufacturer's insufficient consideration for the user's ability to follow the instructions. While it is easy to put the scalpel in the hands of a surgeon and expect them to make the correct cut, it is an abandonment of Deming's first item in Profound Knowledge; the appreciation for a system. The ignoring of expected errors due to normal use is to ignore the reality of the customer's experience. In multiple studies of anesthesia procedures the frequency of user error as defined as incidents involving human error as a proportion of all incidents exceeded 70% with the rate as high as 80% in infusion pump studies (Ward & Clarkson 2004).  


Fairbanks and Wears (2008) define the issue well when they state, "Technologies often fail to deliver their promised benefits when they are not designed in a way that matches the needs, cognitive processes, and environments of the intended users." (p. 519). This design input becomes more critical as the medical device user is increasingly the patient rather than the physician. Blood glucose monitors, telemetry devices, steroid inhalers and many other devices are used by individuals with wide ranging differences in intellectual and physical ability.  


Rogers, Mykityshyn, Campbell and Fisk (2001) describe how a home-use blood glucose meter could claim three easy steps but rely on the execution of fifty two sub-steps to achieve a proper reading. Frustration would be expected in an elderly user with only a high school education. While 1.64 million Americans received Medicaid home care in 1995, that number exploded to 8.3 million Americans in 2004 and the trend is expected to continue (Story, 2010). This shift in the definition of the medical device consumer will continue with the aging of the population. Regulatory bodies have responded by generating guidance to the correct identification of the users of medical devices. The benefit of advance consideration of design features, and the relationship between risk management (the management of device failures which pose hazards to patients) and financial return, is noted in the FDA's design control guidance,


Risk management begins with the development of the design input requirements. As the design evolves, new risks may become evident. To systematically identify and, when necessary, reduce these risks, the risk management process is integrated into the design process. In this way, unacceptable risks can be identified and managed earlier in the design process when changes are easier to make and less costly." [emphasis added] (FDA Center for Devices and Radiological Health, 1997, p. 5)


Shah and Robinson (2007) list the expected financial fruit of ignoring the user's needs and abilities as including development costs, product failure and loss of sales and profits. In contrast to the earlier examples of massive settlements impacting a company's financial health, today's omens portend that the inability to consider the new users of medical devices will lead to a company that suffers the chronic ailment of substandard sales volume.


In the medical device industry, the cost of a single quality failure can eclipse the cost of a quality program. Past failures to understand fully the device and the customer has led to billion dollar settlements against the medical device companies involved. While the highly visible legal actions attract headlines, the current shift in the definition of the medical device user impacts the long term viability of products. Rather than suffering publicized recalls, the failure to capitalize on guidance to increase the usability of devices could lead to the quiet exit from the market by products which the user finds to be simply not worth the bother to use.









Brown University. (2007, Spring). Major recalls of organ replacement devices. Retrieved from


Fairbanks, R. J. & Wears, R. L. (2008). Hazards with medical devices: The role of design. Annals of Emergency Medicine. 52.5, 519-521.


FDA Center for Devices and Radiological Health. (1997, March 11). Design control guidance for medical device manufacturers; This guidance relates to FDA 21 CFR 820.30 and sup-clause 4.4 of ISO 9001. Retrieved from


Kastetter, T. E. (1999). Quality concepts and products litigation. The TQM Magazine, 11.4. 264.

Story, M. F. (2010). Medical devices in home health care. In S. Olson (Ed.), The role of human factors in home health care: Workshop summary (145-172). Washington DC: The National Academies Press.

Rockoff, J. D. & Searcey, D. (2011, July 8). Hip joints set off new rush to court. The Wall Street Journal, Retrieved from


Rogers, W. A., Mykityshyn, A. L., Campbell, R. H. & Fisk, A. D. (2001, Winter). Analysis of a "simple" medical device. Ergonomics in Design pp. 6-14. Retrieved from


Shah, G. S. S., & Robinson, I. (2007). Benefits of and barriers to involving users in medical device technology development and evaluation. International Journal of Technology Assessment in Health Care, 23.1, 131-137.


Stephens, K., D'Urso, S. & Holmes, P. (2006). The Sulzer hip replacement recall crisis: A patient's perspective. In S. May (Ed.), Case studies in organizational communication: Ethical perspectives and practices. (125-138). Thousand Oaks, CA: Sage Publications.

Ward, J. R. & Clarkson, P. J. (2004). An analysis of medical device-related errors: Prevalence and possible solutions. Journal of Medical Engineering & Technology. 28.1, 2-21.

Wizemann, T. (Ed.). (2011). Food and drug administration postmarket surveillance activities and recall studies of medical devices. In, Public health effectiveness of the FDA 510(k) clearance process: Measuring postmarket performance and other select topics: Workshop report. (pp. 5-21). Washington, DC: The National Academies Press.




ASQ Certification Exams


Application Deadline

April 12, 2013


Late Application

Fee ($50) Deadline

April 17, 2013


Exam Date

June 1, 2013




Quality Engineer(CQE)

Quality Auditor(CQA)

Six Sigma Green Belt (SSGB)

Software Quality Eng. (CSQE)

Quality Improvement Assoc (CQIA)

Calibration Technician(CCT)

Quality Process Analyst (CQPA)


Application Deadline

August 16, 2013


Late Application

Fee ($50) Deadline

August 21, 2013


Exam Date

October 5, 2013  




Six Sigma Black Belt(SSBB)

Mgr of Qual/Org Excel (CMQ/OE)

Quality Inspector(CQI)

Quality Technician(CQT)

Biomedical Auditor(CBD)

Reliability Engineer(CRE)

HACCP Auditor(CHA)





for more information.


Cal State Dominguez Hills BSQA & MSQA Programs

sponsor certification preparation courses, See certification

page on


Is it time for recertification?

Send your package to Joe DeSimone,

Recertification Chair at

P.O. Box 1291, San Pedro, CA90731.




Time: 5:30 - 6:00 Networking & Dinner

6:00 - 8:00 Meeting


CSUDH Extended Education Bldg

1000 Victoria St., Carson, CA 90745

Contact: Lane Parrott, Chair

(310) 489-9018

[email protected],

Dates: 1st Wednesday of the Month




Officers & Committee Chairs of ASQ Los Angeles Section 700


CHAIR: Lane Parrott - (310) 489-9018 - [email protected]


SECRETARY: Catherine Martin - 310-616-0936 [email protected]

TREASURER: Jim Morrison -(310) 541-1417 - [email protected]

PAST CHAIR/Executive Advisory: Chen Low - (310) 334-7044 - [email protected]
Arrangements:  Chen Low - (310) 334-7044 - [email protected]

 Job Listing: Armen Yeghoian- 818-912-9272 - [email protected]

Website Chair: Alan Wang - (310)383-2393 - [email protected]

Membership: Lisa Uhrig - - 310-283-1197 [email protected]

 Education: Bill Trappen - (760)723-7718 -[email protected]

CSUDH Liaison: Milt Krivokuca - (949) 892-7994 - [email protected]

Certification: Joe DeSimone - (424) 772-6371 -[email protected]

Re-certification: Joe DeSimone - (424) 772-6371 - [email protected]

Newsletter: Harold Martinez - (310) 214-1606 -[email protected]

Awards and Recognition: Imre Fischer -(949)493-3914 - [email protected]

Quality Management Process (QMP): Lane Parrott - (310) 489-9018 - [email protected]

Financial Audit: Michael Schaffer - (310)895-0802  [email protected]

Simon Collier Quality Award:  Imre Fischer - (949) 493-3914 [email protected]

    Programs: Open

Publicity & Advertising Chair: : Alan Wang - (310)383-2393 - [email protected] 

Voice of the Customer: Kathleen Laing - (310) 813-7646 [email protected]