Refreshers and Tutorials
Tutorials: One, two and three day pre-conference tutorials will be conducted on October 9, 10 & 11, 2017. These great pre-conference Tutorials that will benefit the attendees or target audience and enhance your management, auditing, and other quality related skills and knowledge. These are a special offering outside the conference for an additional fee unless otherwise indicated.
Instructor Bios Click here to download the instructor bios.
|Monday, October 9, 2017 – Wednesday, October 11, 2017|
|#9983ILT||Certified Quality Auditor Exam Refresher|
|WKSP13||Certified Software Quality Engineer Preparation Overview|
|Tuesday, October 10, 2017 – Wednesday, October 11, 2017|
|WKSP3||ISO 9001:2015 Internal Auditing|
|Monday, October 9, 2017|
|WKSP1||Optimizing Risk Assessment Interviews|
|WKSP14||Synthesizing the ‘Process Approach’ via the P-D-C-A model|
|Tuesday, October 10, 2017|
|WKSP2||Keys to being an Effective Audit Manager|
|WKSP7||The Supplier Audit Program – Managing Organizational Risk and Meeting ISO 9001:2015 Requirements|
|WKSP8||Pharmaceutical GMP Professional (CPGP) Review Day and Preparation for the Exam|
|WKSP9||Certified HACCP Food Safety Auditor (CHA) Exam Prep|
|Wednesday, October 11, 2017|
|WKSP4||Evolving the Internal Audit Process|
|WKSP5||A Brief Introduction to Supplier Management|
|WKSP6||An Introduction to Statistical Process Control and Acceptance Sampling|
Monday, October 9, 2017 – Wednesday, October 11, 2017
8:00 AM – 5:00 PM Workshops
Presented by: Kevin Posey
8:00am – 5:00pm (Monday, Tuesday, and Wednesday)
This workshop will be an exam refresher to help experienced auditors become better prepared for the CQA exam. The basis for the exam is the CQA Body of Knowledge and class discussion will include an overview of the CQA BoK offering participants a better understanding of the basic principles and applications that will appear on the exam. All course participants will receive a three ring binder containing the entire power point presentation and the CQA Handbook, Fourth Edition as the course text.
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Presented by: Linda Westfall
8:00am – 5:00pm (Monday, Tuesday, and Wednesday)
The ASQ Certified Software Quality Engineer (CSQE) Body of Knowledge (BoK) is a comprehensive guide to the “common knowledge” software quality engineers should possess about the knowledge areas of:
• Software quality management. The processes and activities involved in setting the organization’s strategic quality goals and objectives, establishing organizational, project, and product quality planning, and providing the oversight necessary to ensure the effectiveness and efficiency of the organization’s software quality management system.
• Software quality engineering. The processes and activities needed to define, plan, and implement the quality management system for software-related processes, projects, and products. This includes defining, establishing, and continuously improving software-related systems, policies, processes, and work instructions that help prevent defects and build quality into the software.
• Software quality assurance. The planned and systematic set of all actions and activities needed to provide adequate confidence that the:
• Software work products conform to their standards of workmanship and that quality is being built into the products
• Organization’s quality management system (or each individual process) is adequate to meet the organization’s quality goals and objectives, is appropriately planned, documented, and improved, is being followed, and is effective and efficient.
• Software quality control. The planned and systematic set of all actions and activities needed to monitor and measure software projects, processes, and products to ensure that special causes have not introduced unwanted variation into those projects, processes, and products.
• Software verification and validation. The processes and activities used to ensure that software products meet their specified requirements and intended use. Verification and validation help ensure that the “software was built right” and the “right software was built.”
• Soft skills. A software quality engineer also needs what are referred to as the “soft skills” to be effective in influencing others toward quality. Examples of “soft skills” include leadership, team building, facilitation, communication, motivation, conflict resolution, negotiation, and more.
This tutorial contains information and guidance that supports topics of the 2016 version of the CSQE BoK upon which the CSQE exam is based. Armed with the knowledge presented in this tutorial to complement the required years of actual work experience, qualified software quality practitioners may feel confident they have taken appropriate steps in preparation for the ASQ CSQE exam. However, the goals for this tutorial go beyond it being a CSQE exam preparation guide. It is designed not only to help the software quality engineers but as a resource for auditors, software development practitioners, project managers, organizational managers, other quality practitioners, and other professionals who need to understand the aspects of software quality that impact their work.
1. Armed with the knowledge presented in this tutorial to complement the required years of actual work experience, qualified software quality practitioners may feel confident they have taken appropriate steps in preparation for the ASQ CSQE exam. Attendees will receive the workbook from our 5-day CSQE Preparation course, which includes detailed notes on all the topics from the ASQ Certified Software Quality Engineer Body of Knowledge. This allows students to study the more general topics not covered during this tutorial. It also provides an excellent reference for attendees to take into the open book CSQE exam.
2. Students will learn techniques that they can use to implement and improve software quality practices in their organization.
3. Students will practice CSQE example questions during the tutorial and receive a CD with three complete 160 practice exams (including answers, explanations and CSQE references) they can use to practice for the exam.
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Tuesday, October 10, 2017 – Wednesday, October 11, 2017
• Quality Management Principles
• The ISO 9001 Standard Explained
• The ISO 9001 Family of Standards
During this workshop, students will explore effective auditing techniques, interviewing skills, communication skills, and teamwork concepts through a series of interactive workshops, simulated audits, tutorials, and case studies. Training includes a discussion about internal auditing metrics. Specific topics include:
• Documentation for ISO 9001
• The audit cycle and ISO 19011
• Introduction to Quality Audits
• Management of Audit Programs
• Audit Planning and Preparation
• Scope and Objectives
• Audit Plan
• Performing the Audit
• Opening Meeting
• Quality Audits
• Conducting the Audit
• Writing Nonconformity Statements
• Writing Nonconformities (using CARs)
• Closing Meeting
• Summary Statement and Closing Meeting
• Completing the Audit Report
• Corrective Action and Close Out (using CARs)
• Verification and Close Out
• Enhance their understanding of process-based, metric-driven auditing techniques
• Learn the requirements of ISO 9001:2015 and understand its inter-relationship with other elements of the ISO family of standards. Role-play exercises give students practical experience with auditing
One Day Workshops
Auditors, in many organizations, face an uphill battle when building rapport and strong relationships with clients. The face-to-face time afforded during the interview process can not only be valuable from a risk assessment perspective, but can play a pivotal role in many other facets of the assessment/audit process, including:
• Building rapport/relationships
• Assessing fraud risk
• Understanding of the controls and process
• Understanding the rumor mill
• Getting a better feel for how the process works (versus how it is documented)
• Learn the step-by-step audit interview process and learn best practices for each step.
• Learn how to listen actively and read physical cues.
Presented by: Jeff Bostow
This pre-conference workshop / tutorial will actively explain and demonstrate what is referred to as “The Process Approach” in ISO 9001:2015. The specific content of how The Process Approach is displayed in this session can be applied to any organization and per any quality management system. Since all organizations use processes to achieve their interested parties’ objectives, the content provided here will accurately display and depict a process as “a risk-assessed set of interrelated activities that use inputs and a value-added transformation to deliver an intended output (typically, the delivery of a product and/or a service; but more specifically, the attainment of a defined goal).”
The Process Approach will be oriented and grounded in the Shewhart-Deming P-D-C-A cycle of continuous development and improvement. From the P-D-CA model, the content will seamlessly blend from an initial concept into a process view of the cycle and will display specific functional steps of each cycle piece, (e.g., the ‘Plan’ component will be comprised of the following five steps: 1. Identify and Select the Priority Process, 2. Conduct a Risk Mitigation Assessment, 3. Document the Work Process, 4. Identify Interested Party and External Provider requirements, and 5. Develop Indicators and Build the QMS). The ‘Do’ component will be presented as an action (more specifically a project) plan (Embrace the Present). The final cycle pieces of ‘Check and Act’ will explore both process stability and process capability using continuous (variables) data examples and will examine where the existence of nonvalue time and space may inadvertently co-exist. This exposure provides the Quality Auditor with the ability to be more insightful when conducting either partial or full system assessments (Prepare for the Future) upon conference adjournment.
Presented by: Lance Coleman
• Understanding risk based thinking as it applies to the supplier audit program
• ISO 9001:2015 requirements relating to supplier monitoring and control
• How to conduct a successful risk based supplier audit
• External Provider Management Matrix
• Useful templates for use in supplier auditing
Who should attend?
• Supply Chain professionals
• Anyone who participates in supplier auditing
Presented by: Teresa Sowinski
• Discuss, study and analyze public information and real cases as currently posted at the FDA website
• Gain different perspectives on how to approach audit findings based on current GMPs interpretation
• Share experience among participants addressing common questions and further gaining knowledge
• Prepare attendees to take the Certified Pharmaceutical GMP Professional (CPGP) examination
Presented by: Aura Stewart and Tatiana Miranda
• Learn how to identify audit risk and appropriate audit planning tools and techniques
• Learn how to manage the audit process from planning to follow-up
• Discover the best interpersonal and team building skills
• Discuss audit communication and budgeting and forecasting techniques
• Further understanding of the audit report creation process
• Learn more about public speaking and presentation best practices
1) Introduction and Background
b. auditor to manager
a. Audit manager roles
b. Audit preliminary work
c. Audit preliminary risk assessment
3) Managing an Audit Engagement
a. Appropriate audit planning
b. Developing an audit work program
c. Managing a budget and schedule
d. Delineation of duties
e. Reviewing an audit file
4) Managing an Audit Team
a. Personality types/styles
b. Managing minimal age differences
c. Deadline management
5) Internal Audit Wrap Up
a. Audit reporting
b. Effective exit conferences
c. Audit follow-up
6) Managing Up
a. Managing expectations
b. To commit or not to commit
a. Interpersonal Skills
b. Managing the Auditee
8) Time Management
9) Public Speaking and Presentations
10) Creating/Reviewing Audit Findings and Reports
• Criteria to identify key/significant controls
• Identify the most efficient controls to test
• Understand the differences between control
• Learn about ways to test controls the most efficiently and effectively
b. Assessment modes
c. Assessing emerging risk
1. Percent of audit cycle – new vs recurring audits
2. Components of audit planning
3. Kick off meeting- Who/What/Why and for how long?
4. Formality of engagement risk assessment
5. Risk categories
6. Using a true top-down risk-based approach
7. What should I test and why?
8. Building an effective and efficient audit work program
1. Percent of Audit Cycle – New versus Recurring Audits
2. Timing & Contents of PBC List
3. Sampling Methodology
4. What support to keep and why?
5. Presenting Observations to Clients
1. Percent of Audit Cycle – New versus Recurring Audits
2. Do We Even Need a Formal Report?
3. Timing of the Audit Report
4. Audit Reports – Emerging Formats
5. What Words NOT to Use & What to Replace them with
1. Correlation between Finding Type and Follow-Up Method necessary
2. Timing of Follow-Up
4) Transparency and Continuous Communication
Presented by: Steven Schuelka
• Learning how to construct Attribute and Variables
• Fundamental knowledge of Acceptance Sampling
Why is a Supplier Management Program Necessary?
Where do we start?
Building Your Supplier Management Tool Kit
Basic Inventory of Your Existing Supplier Management Base
Improving Your Existing Supplier Base
Selecting New Suppliers
Supplier Certification and Ship-to-Stock
While this course is just a brief introduction to these topics without the hands on application included in the full version, it will give participants the opportunity to explore these topics as well as the resources available to them within ASQ. These elements also align with the new CSQP, allowing participants to learn about topics that need to be considered in preparation for the exam, although this course is not an exam prep course. Participants will also have the opportunity to share their own experiences and learn from each other as time allows.
• Be equipped with knowledge of the functional roles in supplier management
• Learn tools of a complete supplier management program
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