North Jersey ASQ Spring

Quality Conference

ASQ CERTIFICATIONS:
RAISING YOUR
MARKETABILITY,
VALUE, & KNOWLEDGE

Robert D. Seltzer
Regulatory Compliance Manager
GlaxoSmithKline
Robert.d.seltzer@gsk.com

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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

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 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

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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

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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

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

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 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

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 Top Level Body of Knowledge (BoK)
for the Certified Quality Auditor (CQA)

I. Auditing Fundamentals
II. Audit Process
III. Auditor Competencies
IV. Audit Program and Business Applications
V. Quality Tools and Techniques

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 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 what
not to inspect
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 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
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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
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 Benefits this Speaker Has Accrued from
Earning and Maintaining the CQA
• Became sole internal quality auditor at BioMerieux 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 10yr)
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Top Level BoK 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

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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
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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
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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

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 Example Benefits Accrued from Earning & Maintaining the CQE

I. Gave me the tools at BioMerieux Vitek with which to:

a) Implement SPC and capability trending at
BioMerieux 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 GlaxoSmithKline 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.

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 Top Level BoK 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
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Exam Format: Four-hour total,
150 Multiple choice questions (3-1/4 hr) +
2 Constructed response (essay) questions (over 45 min)

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 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
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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.
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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
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 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.
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 Top Level BoK 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
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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.

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 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.
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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
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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
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 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 (21CFR
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?

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 INVENT A NEW ASQ
CERTIFICATION THAT
MANY PEOPLE WILL
SEEK!

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 Propose:
(FD&C Division-Sponsored)

ASQ Certified
Pharmaceutical GMP
Professional (CPGP)
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Arguments Against an Arguments For an ASQ Certification of a
ASQ Certification of a Pharmaceutical Compliance Professional
Pharmaceutical
Compliance Prof’l
1.0 I can’t see how 2.0 Keeping up with the ever-changing BoK (in line
cramming for and with the “C” in CGMP), enables a pharma
sitting for this ASQ compliance prof’l--or anyone who must
certification exam understand drug CGMPs--to calibrate his/her
possibly adds to my
knowledge or my staying up-to-date w/ the subject w/ many other
marketability. people. Certifications are used by many, if not
most, pharmaceutical companies in their
1.1 Even if a person has candidate screening.
been a pharmaceutical 2.1 On the contrary, now a veteran pharma
quality auditor for ten
compliance prof’l can take and pass a true test
plus years, now he/she
would be in jeopardy of of his/her many areas of knowledge and
a “black mark” or interpretation in CGMPs. Most companies allow
worse if he/she did not an ASQ certification examinee to retake the
pass the exam. exam multiple times.

1.2 If I take this exam and 2.2 Recertification in ASQ entails accumulating at
pass, the next thing I least 18.0 recertification units via course or
know is they will be seminar attendance, teaching, article/book-
requiring test-taking writing, participating on relevant committee(s),
recertification every 3 24
yr. & simply remaining in the profession, etc.
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
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