Overview of ASQ Certified Quality Auditor (CQA)

An overview of ASQ Quality Auditor (CQA) certification program with tips for passing exam

http://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/

1. Overview of
ASQ Certified Quality Auditor
(CQA)


Seetharam Kandarpa,
ASQ CQA & ASQ CPGP
Chair- Healthcare
ASQ Mumbai LMC

2. Contents
•About Author
•Overview of Mentoring Classes for ASQ CQA
•Overview of ASQ
–About ASQ
–ASQ Membership
–ASQ Certification
•Overview of ASQ CQA
–Basics
–Requirements
–Body of Knowledge
–Application Process
–Examination
–Recertification

3. About Author







•Having 14+ years of versatile industrial experience in QA and Production functions at
API/ Formulation facilities (approved by various regulatory agencies USFDA, TGA,
MHRA, WHO etc.) of top pharma companies in India such as Aurobindo Pharma Ltd.,
Mylan Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Ipca Laboratories Ltd. and
Abbott Healthcare Pvt. Ltd.

•Having experience in handling Regulatory Inspections of USFDA, MHRA, WHO, TGA,
KFDA and PMDA.

•Having Training on Culture of Quality and Data Integrity Assurance by Dr. Ajaz S
Hussain.

•Having Training and certification on 'Cleaning Validation' by Destin A. Leblanc.


Seetharam Kandarpa, ASQ CQA & ASQ CPGP
Chief Manager Quality Assurance
Abbott Healthcare Pvt. Ltd.
http://seetharamkandarpa.webnode.in
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4. OVERVIEW OF
MENTORING CLASSES FOR
ASQ CQA

5. Mentoring Classes for ASQ CQA
•What?
–Free mentoring classes to provide guidance on basics of ASQ CQA
(Certified Quality Auditor) certification program and tips to pass the
exam

•Why?
–To take a minute part, as a responsible individual, in a big mission of
improving continuously quality of products/ services for society through
mentoring professionals aspiring to become Certified Quality Auditor

•Who?
–Suitable to the professionals plan to become Certified Quality Auditor by
ASQ

•How & Where?
–Through series of webinars
–Keepings recordings at YouTube forever

Continues…

6. Mentoring Classes for ASQ CQA
•When?
–As per below calendar
For Timely Updates:
•JOIN THE GOOGLE HANGOUT GROUP
https://hangouts.google.com/group/mAWt5BYDGX9amObn1
•http://seetharamkandarpa.webnode.in/asq-cqa/ Back to Contents

7. OVERVIEW OF ASQ

8. ASQ – A Global Voice of Quality


ASQ is the world’s leading
community of people passionate
about quality – experienced individuals and
companies who strive for continual improvement
and help each other achieve it.
Continues…

9. About ASQ
•ASQ (American Society for Quality) (www. asq.org or asq.org.in)

–ASQ provides the global community with the expertise, tools, and solutions to help
organizations and individuals improve the products, services, and experiences we rely upon
for our safety, health, and daily lives. ASQ’s mission is to increase the use and impact of
quality in response to the diverse needs of the world.

–Founded in 1946, ASQ has been at the forefront of the quality movement. ASQ traces its
beginnings to the end of World War II, as quality experts sought ways to sustain quality
improvement. Today, ASQ continues to support innovations in many fields.

–ASQ provides the quality community with training, professional certifications, and knowledge

to a vast network of members of the global quality community.

–Headquartered in Milwaukee, Wisconsin, USA, ASQ champions people passionate about
quality in more than 150 countries. ASQ operates Regional Centers in North Asia, South Asia,
Latin America and the Middle East/Africa. ASQ’s global offices provide local access to the
quality community, career development, credentials, knowledge, and information services.

–Read ASQ’s online brochure
.
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10. ASQ Membership
•Why Join ASQ?
–Whether you’re looking to connect with other professionals, advance your
knowledge and career, or grow your reputation as a thought leader, ASQ got the
membership that’s right for you.

•ASQ offers the following memberships:
–Full membership

–Associate membership
–Student membership
–Senior membership
–Fellow membership (members only)
–Honorary membership
–Enterprise Quality Roundtable organizational membership
–Corporate organizational membership

•Membership Benefit Matrix
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11. ASQ Certification
•ASQ certification is a formal recognition by
ASQ that an individual has demonstrated a
proficiency within, and comprehension of, a
specific body of knowledge. Nearly 300,000
certifications have been issued to dedicated
professionals worldwide.

•Recognized globally, ASQ certifications are
essential development tools that help quality
professionals show they’re on top—of
regulations, of expertise, and of industry
standards. People with ASQ credentials don’t
just improve their companies’ bottom lines; they
build careers.

•For more details:
–asq.org/cert

–8 step guide
–ASQ Certification and Certification Preparation Tools


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12. ASQ Certification
•ASQ offers 18 certifications, many translated into four languages,
including basic quality tools, Six Sigma programs, quality engineering,
and management.
•Biomedical Auditor
CBA
•Calibration Technician CCT
•HACCP (Food Safety) Auditor CHA
•Manager of Quality Organizational
Excellence CMQ/OE
•Master Black Belt CMBB
•Pharmaceutical GMP Professional
CPGP
•Quality Auditor CQA
•Quality Engineer CQE
•Quality Improvement Associate CQIA
•Quality Inspector CQI
•Quality Process Analyst CQPA
•Quality Technician CQT
•Reliability Engineer CRE
•Six Sigma Black Belt CSSBB
•Six Sigma Green Belt CSSGB
•Six Sigma Yellow Belt CSSYB
•Software Quality Engineer CSQE
•Supplier Quality Professional
CSQP
NOTE: Don’t Confuse Certification With a Training Certificate
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13. OVERVIEW OF
ASQ CQA

14. Basics
•The Certified Quality Auditor is a professional who understands the
standards and principles of auditing and the auditing techniques of
examining, questioning, evaluating and reporting to determine a
quality system's adequacy and deficiencies.

•The Certified Quality Auditor analyzes all elements of a quality
system and judges its degree of adherence to the criteria of industrial
management and quality evaluation and control systems.

•Quality Auditor Certification Brochure


•Certified Quality Auditor Body of Knowledge
For More Details: asq.org/cert/quality-auditor
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15. Requirements
•Work Experience

–Candidates must have worked in a full-time, paid role. Paid intern, co-op or any
other course work cannot be applied toward the work experience requirement.

–Candidates must have eight years of on-the-job experience in one or more of
the areas of the Certified Quality Auditor Body of Knowledge.

–A minimum of three years of this experience must be in a decision-making
position. "Decision-making" is defined as the authority to define, execute, or
control projects/processes and to be responsible for the outcome. This may or may
not include management or supervisory positions.

–For candidates who were certified by ASQ as a quality engineer, reliability
engineer, supplier quality professional, software quality engineer or quality
manager, the experience used to qualify for certification in these fields applies to
certification as a quality auditor.

For More Details: asq.org/cert/quality-auditor

Continues…

16. Requirements
•Education


–Candidates who have completed a degree from a college, university or
technical school with accreditation accepted by ASQ, part of the eight-
year experience requirement will be waived, as follows (only one of these
waivers may be claimed):

•Diploma from a technical or trade school — one year will be waived
•Associate degree — two years waived
•Bachelor’s degree — four years waived
•Master’s or doctorate — five years waived

–Degrees/diplomas from educational institutions outside the United States
must be equivalent to degrees from U.S. educational institutions.

For More Details: asq.org/cert/quality-auditor

Continues…

17. Requirements
•Expectations


–Must possess the knowledge and ability to effectively conduct different
types of audits as appropriate for the method, relationship, or purpose of
the audit, and must recognize the effect those audit types will have on the
audit scope and outcomes.

–Must be able to audit in a professional, ethical, and objective manner
using and interpreting applicable standards or requirements, with an
awareness of potential legal and financial ramifications.

–Must be able to effectively plan, communicate, and execute an audit
within its defined scope, including scheduling resources, conducting
necessary meetings in performance of the audit, and using appropriate
techniques to gather, identify, and classify objective evidence.
For More Details: asq.org/cert/quality-auditor

Continues…

18. Requirements
•Expectations


–Must be able to verify, document, and communicate audit results,
develop an audit report, and evaluate the effectiveness of corrective
action and follow up.

–Must possess interpersonal skills to resolve conflict, conduct interviews,
and make presentations while participating as an audit team member,
and must possess knowledge of the unique responsibilities of the lead
auditor and team facilitator.

–Must be able to select appropriate quality and auditing tools and
techniques and use them effectively in a variety of in practical
applications.
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For More Details: asq.org/cert/quality-auditor

19. Body of Knowledge
•The topics in this Body of Knowledge include subtext explanations and the
cognitive level at which the questions will be written.

•This information will provide useful guidance for both the Exam Development
Committee and the candidate preparing to take the exam.

•The subtext is not intended to limit the subject matter or be all-inclusive of
that material that will be covered in the exam. It is meant to clarify the type of
content that will be included on the exam.

•The descriptor in parentheses at the end of each entry refers to the maximum
cognitive level at which the topic will be tested. A complete description of
cognitive levels is provided at the end of this document.
For More Details: asq.org/cert/quality-auditor

Certified Quality Auditor Body of Knowledge
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20. Body of Knowledge
For More Details: asq.org/cert/quality-auditor
I. Auditing Fundamentals (27 Questions)
•A. Types of quality audits B. Purpose and scope of audits
•C. Criteria to audit against D. Roles and responsibilities of audit participants
•E. Professional conduct and consequences for auditors
II. Audit Process (42 Questions)
•A. Audit preparation and planning B. Audit performance
•C. Audit reporting D. Audit follow-up and closure
III. Auditor Competencies (25 Questions)
•A. Auditor characteristics B. On-site audit resource management
•C. Conflict resolution D. Communication and presentation techniques
•E. Interviewing techniques F. Team dynamics
IV. Audit Program Management and Business Applications (30 Questions)
•A. Audit program management B. Business and financial impact
V. Quality Tools and Techniques (26 Questions)
•A. Basic quality and problem-solving tools B. Process improvement techniques
•C. Basic statistics D. Process variation
•E. Sampling methods F. Change control and configuration management
•G. Verification and validation H. Risk management tools
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21. Body of Knowledge
•Levels of Cognition Based on Bloom’s Taxonomy – Revised (2001)
–Remember
•Recall or recognize terms, definitions, facts, ideas, materials, patterns, sequences, methods, principles,
etc.
–Understand
•Read and understand descriptions, communications, reports, tables, diagrams, directions, regulations,
etc.
–Apply
•Know when and how to use ideas, procedures, methods, formulas, principles, theories, etc.
–Analyze
•Break down information into its constituent parts and recognize their relationship to one another and how
they are organized; identify sublevel factors or salient data from a complex scenario
.
–Evaluate
•Make judgments about the value of proposed ideas, solutions, etc., by comparing the proposal to specific
criteria or standards.
–Create
•Put parts or elements together in such a way as to reveal a pattern or structure not clearly there before;
identify which data or information from a complex set is appropriate to examine further or from which
supported conclusions can be drawn.
For More Details: asq.org/cert/quality-auditor

Mapping Questions vs Levels of
Cognition
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22. Application Process
•Fee Details:
–ASQ Members $348 (save $150) / ₹23,000* (Save ₹9,900)
–Non-members $498/ ₹32,900*
–Retakes $298/ ₹19,700*

•Become a Member
•Apply Now
•Download an Application (CBT Delivered Exams) (PDF,
148 KB)

*Price includes $70/ ₹4600 non- refundable fee.

For More Details: asq.org/cert/quality-auditor
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23. Examination
•Each certification candidate is required to pass an examination that consists
of multiple-choice questions that measure comprehension of the Body of
Knowledge.

•Computer Delivered - The CQA examination is a one-part, 165- multiple
choice question, five-and-a -half-hour exam and is offered in English only.
150 multiple choice questions are scored and 15 are unscored.

•Paper and Pencil - The CQA examination is a one-part, 150- multiple choice
question, five-hour exam and is offered in English and Spanish in certain
locations.

•
All examinations are open book, with the exception of the constructed
response (essay) portion of the CMQ/OE exam. Each participant must bring
his or her own reference materials. Use of reference materials and
calculators is explained in the FAQs.
For More Details: asq.org/cert/quality-auditor
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24. Examination
•Case Studies




–The CQA examinations will continue to present a number of case studies. Each
case study will include a brief scenario outlining critical details about an audit
situation. In addition, each case study will be supported by related audit
documents.

–Approximately 15 percent to 20 percent (25-30 questions) of the test will be
devoted to these case studies.

–Although the questions related to these cases will use the same four-choice
answer format as the rest of the test, the use of scenario details and sample
documents will allow the candidates to apply their critical thinking skills in
evaluating realistic situations and accompanying documents, memos, etc.


For More Details: asq.org/cert/quality-auditor

Continues…

25. Examination
•Computer-Based Testing Dates
–ASQ certification examinations are delivered by ASQ's testing partner, Prometric.
The examination scheduling instructions in your eligibility letter will direct you to a
section of Prometric's website, where you can select and schedule your
examination date and location.

•Prepare for Exam
–References

–Interactive sample exam
–Paper-and-pencil sample exam
–IS/ISO 19011 (2011): Guidelines for Auditing Management - Law.Gov




For More Details: asq.org/cert/quality-auditor
Continues…

26. Examination

–Books
•The ASQ Auditing Handbook, Fourth
Edition
•Quality Audits for Improved
Performance, Third Edition
•Internal Quality Auditing
•Juran's Quality Handbook, Seventh
Edition
•The Internal Auditing Pocket Guide,
Second Edition
•ISO 9001:2008 Internal Audits Made
Easy, Fourth Edition
•How to Audit the Process- Based QMS
•The Quality Toolbox, Second Edition
•Auditing Beyond Compliance: Using
the Portable Universal Quality Lean
Audit Model
•Advanced Quality Auditing
•Search for more ASQ books



For More Details: asq.org/cert/quality-auditor
•Prepare for Exam
–Training
•Certified Quality Auditor — Classroom
or Web-Based
•After the Audit: Continual
Improvement from Audit Process
•Auditing (CQA) Fundamentals I
•Auditing (CQA) Fundamentals II
•Auditing (CQA) Fundamentals III
•Certified Quality Auditor Question
Bank: CQA Certification Preparation
•Internal Auditing Basics
•Process Auditing Techniques
•Process- Based Auditing
•More Related Training



Continues…

27. Examination
•Is Exam tough or easy?



For More Details: asq.org/cert/quality-auditor

Back to Contents
Exam is neither tough nor easy

28. Recertification
•Recertification

–To maintain the integrity of your Quality Auditor certification, ASQ
requires that you recertify every three years.

–Find out the steps you need to take for recertification.


–CREDENTIAL HOLDERS MUST:
•Obtain 18 recertification units (RUs) within a three-year recertification period.
Or
•Retake the certification exam at the end of the 3-year recertification period.

Fore more details: https://asq.org/cert/recertification


For More Details: asq.org/cert/quality-auditor
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29. Q&A
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30. Thank You
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