North Jersey ASQ Spring Quality Conference ASQ CERTIFICATIONS

North Jersey ASQ Spring Quality Conference ASQ CERTIFICATIONS: RAISING YOUR MARKETABILITY, VALUE, & KNOWLEDGE Robert D. Seltzer Regulatory Compliance Manager Glaxo. Smith. Kline Robert. d. seltzer@gsk. com 1

I. General Intro to ASQ Certifications II. ASQ Certified Quality Auditor III. ASQ Certified Quality Engineer IV. ASQ Certified Manager of Quality/ Organizational Excellence (formerly CQMgr) V. ASQ Certified Biomedical Auditor VI. Being Proposed: ASQ Certified Pharmaceutical CGMP Compliance Professional 2

Key Benefits of Certification to Members • Mark of technical excellence • Implies one is current with emerging technologies • Helps one gain new skills and upgrade proficiency • It’s a source of professional and personal pride • It’s an unmistakable investment in one’s career 3

History of ASQ Certifications Certified Quality Engineer 1968 Certified Quality Technician 1970 Certified Reliability Engineer 1972 Certified Mechanical Inspector 1984 Certified Quality Auditor 1987 Certified Quality Manager 1995 Certified Software Quality Engineer 1996 Certified HACCP Auditor 2000 4

History of ASQ Certifications Certified Quality Improvement Associate 2001 Certified Six Sigma Black Belt 2001 Certified Biomedical Auditor 2002 Certified Calibration Technician 2003 Certified Quality Process Analyst 2005 Certified Six Sigma Green Belt 2005 Certified Pharmaceutical GMP Professional 2008 5

No. of Certifications Issued as of Dec, 2007 CQE CQA CQT CQI CMQ/OE (Mg’r) CRE Six Sigma Black Belt CQIA CSQE CCT HACCP CBA (Biomedical) 52, 412 37, 215 22, 980 12, 308 11, 268 7, 745 6, 295 4, 949 4, 498 715 499 368 6

APPROACH FOR EACH CERT A. Top Level Body of Knowledge (BOK) Categories B. Exam Format and Example of Exam Questions C. Benefits this Speaker Has Accrued from Earning and Maintaining this Cert 7

Top Level Body of Knowledge (Bo. K) for the Certified Quality Auditor (CQA) I. III. IV. V. Auditing Fundamentals Audit Process Auditor Competencies Audit Program and Business Applications Quality Tools and Techniques 8

CQA Exam Format • • All Answers Are Multiple Choice 15 -20% of Exam Consists of Case Studies w/ Multiple Choice Questions • Exam is a Total of Five (5) Hours Long ----------------------------------------- Several Example Questions Follow: I. A classification of characteristics makes it possible to a) Separate the “vital few” from the “trivial many” kinds of defects b) Direct the greatest inspection effort to the most important quality characteristics c) Establish inspection tolerances d) Allow the inspector to choose what to inspect and 9 what not to inspect

Example CQA Questions Cont’d II. A control chart is used for the primary purpose of: a) Setting specifications and tolerances b) Comparing operations c) Determining the stability of a process d) Accepting or rejecting products -------------------------------------------------III. When a member of the auditee’s staff volunteers tidbits of information that are informative to the auditor, the auditor should: a) Disregard entirely, as the auditee may be trying to divert the auditor from something he is pursuing a the time b) Terminate the audit c) Listen carefully and by further questioning and more investigation, try to get objective evidence d) Notify the auditee’s supervisor 10

Benefits this Speaker Has Accrued from Earning and Maintaining the CQA • Became sole internal quality auditor at Bio. Merieux Vitek (in vitro diagnostic medical device mfr) Rockland, MA in 1994 • Was recruited by Seragen (now Cambrex Biotech)--parenteral drug company-- to be specifically a Quality Assurance Auditor • Was recruited by SIMS Level I to assume role of RA/QA Manager, with quality systems auditing an important task among several • Worked four (4) years at Fresenius Medical Care-North America auditing its 6 medical device domestic manufacturing plants, 1 drug manufacturing plant, and 18 distribution centers plus various suppliers • Recruited by Schering-Plough into its Global Quality Audits and Compliance-GMP (corporate CGMP auditing) Dept. to share in auditing S-P’s 34 mf’g plants worldwide, various HQ depts, various distribution centers, and occasionally contract manufacturers (for pre-PAI audits) • Have written several articles on quality auditing • Quality auditing has become my primary specialization (esp. last 10 yr) 11

Top Level Bo. K for the Certified Quality Engineer (CQE) I. Management and Leadership in Quality Eng’g II. Quality Systems Development, Implementation, and Verification III. Planning, Controlling, and Assuring Product and Service Development IV. Reliability and Risk Management V. Problem Solving and Quality Improvement VI. Quantitative Methods ---------------------------------------------Exam Format: Five-hour 160 multiple choice questions 12

Several Example Questions--CQE Exam I. Two quantities which uniquely determine a single sampling attributes plan are: a) AQL and LTPD b) Sample size and rejection number c) AQL and producer’s risk d) LTPD and consumer’s risk ------------------------------------------------------II. The probability of getting no defectives in a sample of 5, if the process has been producing 10% defectives is: a) (0. 1)5 b) (0. 9)5 c) 1 - (0. 1)5 d) 1 – (0. 9)5 e) 0. 1 x 0. 9 ------------------------------------------------------III. The concept of accelerated cycling or burn-in program of all devices for six months under normal operating conditions would: a) Reduce premature failures in use b) Improve constant failure rate probability c) Be of little use d) Assure an acceptable quality to the customer 13

Example Benefits Accrued from Earning & Maintaining the CQE I. Gave me the tools at Bio. Merieux Vitek with which to: a) Implement SPC and capability trending at Bio. Merieux Vitek for mf’d lots of VIDAS (product used in infectious disease diagnosis and hormone level measurements and monitoring); and b) Systematize (and provide rationales for) incoming attribute inspection plans on purchased components. II. Gave me the tools at Seragen, SIMS Level I, Fresenius, Schering-Plough, and Glaxo. Smith. Kline with which to: a) Evaluate/audit instrument calibration procedures; b) Audit development reports containing statistical acceptance criteria; and c) Audit component incoming inspection sampling plans. 14

Top Level Bo. K for the Certified Manager of Quality/ Organizational Excellence (CMQ/OE) I. Leadership II. Strategic Plan Development and Deployment III. Management Elements and Methods IV. Quality Management Tools V. Customer-Focused Organizations VI. Training and Development -----------------------------------Exam Format: Four-hour total, 150 Multiple choice questions (3 -1/4 hr) + 2 Constructed response (essay) questions (over 45 min) 15

Several Example Questions—CMQ/OE Exam I. A quality council can be most valuable in: a) Developing top management skills b) Helping control and support the total quality effort c) Developing a linkage to all levels of the organization d) Reviewing key quality cost data ---------------------------------------------------II. When considering human motivation in solving quality problems, it is more important to recognize that: a) Individuals have wants. b) Individuals have different levels of needs. c) Individual motivation matters little in quality problem solving. d) Individuals have numerous conflicts of interest. ---------------------------------------------------III. A thorough analysis of the cause and effect of plant quality problems usually indicates that a major percentage of cause factors are: a) Operator controllable b) Management controllable c) Union controllable d) Customer controllable e) None of the above 16

Example Benefits Accrued from Earning & Maintaining CMQ/OE 1. Forced my reading the entire Juran Handbook, with many insightful concepts and tools, e. g. , Concept of Self Control in a work setting. 2. Added to my quality “tool chest” the method of Force Field Analysis (analytical tool that clarifies opposing arguments toward a proposal), used in quality training session and at a recent meeting. 3. Gave a comprehensive background on team creation, team phases, and rules to follow with teams (used on the job when I was a team leader). 4. I still attend some local seminar every couple years on training effectiveness and when/why people do or do not follow procedures. 5. The necessary reading of Steven Covey gave me a holistic outlook on life activities, both at home and work. Covey’s books point to the following needs: -Physical (maintaining health through exercise and good eating habits) -Spiritual (studying scriptures, recognizing existence of a higher being) -Mental/Emotional/Social -Need to Leave a Legacy The need to leave a legacy and Covey’s Seventh Habit—Sharpen the Saw— have both been my greatest private self-motivation. 17

Top Level Bo. K for the Certified Biomedical Auditor I. Auditing Fundamentals II. Auditing and Inspection Processes III. Biomedical Quality Management System Requirements IV. Technical Biomedical Knowledge V. Quality Tools and Techniques -----------------------------------Exam Format: Four-hour 135 Multiple choice questions Exam was developed to test the applicant’s knowledge of medical devices. Focuses on the understanding of national and international concepts and principles of biomedical quality auditing. Includes related regulation, directives, standards, and guidance. 18

Several Example Questions—CBA Exam I. An auditee has initiated the corrective action process for the nonconformities identified during an audit even before the closing meeting occurs. How could the lead auditor best handle this at the closing meeting? a) Require corrective action plans only for the outstanding items. b) Recommend that the auditee wait until the report is issued to begin corrective action. c) Document only the items that have not been corrected because those that have been corrected are no longer findings. d) Report all nonconformities plus corrective actions already taken. ---------------------------------------------------II. The distribution of radiation throughout a product load can be determined by using which of the following methods: a) Fraction negative b) Survivor curve c) Dose mapping d) Half-cycle ---------------------------------------------------III. When changes are made to a device software system, either during initial development or during post release maintenance what must be conducted: a) White box testing b) Black box testing c) Traceability analysis d) Regression analysis 19

Example Benefits Accrued from Earning & Maintaining CBA 1. It forced me to read or re-read all the Global Harmonization Task Force (GHTF) guidelines, including one on process validation. 2. It really forced me to understand principles of software validation, according to the 2002 FDA guidance. 3. It solidified my complete understanding of US and European medical device regulations, especially the Quality System Regulations (21 CFR 820) and the Medical Device Directive of Europe. 4. The above (1 -3) enabled me to provide comprehensive, informed training modules at Fresenius Medical Care (was a Senior Quality Auditor/Trainer). The main reasons for me to prepare and take this exam was to obtain intrinsic and extrinsic validation of my knowledge of medical device law, regulation, theory, and practice, AND BECAUSE OF THE CHALLENGE OF A NEW EXAM ! 20

What Do You Do When You Think You Have Run out of ASQ Certifications to Obtain? 21

INVENT A NEW ASQ CERTIFICATION THAT MANY PEOPLE WILL SEEK! 22

Propose: (FD&C Division-Sponsored) ASQ Certified Pharmaceutical GMP Professional (CPGP) 23

Arguments Against an ASQ Certification of a Pharmaceutical Compliance Prof’l 1. 0 I can’t see how cramming for and sitting for this ASQ certification exam possibly adds to my knowledge or my marketability. 1. 1 Even if a person has been a pharmaceutical quality auditor for ten plus years, now he/she would be in jeopardy of a “black mark” or worse if he/she did not pass the exam. 1. 2 If I take this exam and pass, the next thing I know is they will be requiring test-taking recertification every 3 yr. Arguments For an ASQ Certification of a Pharmaceutical Compliance Professional 2. 0 Keeping up with the ever-changing Bo. K (in line with the “C” in CGMP), enables a pharma compliance prof’l--or anyone who must understand drug CGMPs--to calibrate his/her staying up-to-date w/ the subject w/ many other people. Certifications are used by many, if not most, pharmaceutical companies in their candidate screening. 2. 1 On the contrary, now a veteran pharma compliance prof’l can take and pass a true test of his/her many areas of knowledge and interpretation in CGMPs. Most companies allow an ASQ certification examinee to retake the exam multiple times. 2. 2 Recertification in ASQ entails accumulating at least 18. 0 recertification units via course or seminar attendance, teaching, article/bookwriting, participating on relevant committee(s), & simply remaining in the profession, etc. 24

As far as questions go for an auditor: “It is better to give than to receive. ” * Any Questions Regarding: -The Four Existing, Discussed Certs-CQA, CQE, CMOQ/OE, CBMA, and -The One Proposed Cert-CPGP * Any Questions Regarding -ASQ Certification Exam Creation Process, -Candidate Application/Qualification, and -Exam Grading 25