Human Error and Management Systems: Designing Errors Out
-
Speaker : JOSE IGNACIO MORA
-
When : Tuesday, August 19, 2025
-
Time : 01 : 00 PM EST
-
Add To Calendar
Refer a Friend
José Mora is a Principal Consultant specializing in Manufacturing
Engineering and Quality Systems. For over 30 years he has worked in the
medical device and life sciences industry specializing in manufacturing,
process development, tooling, and quality systems. Prior to working
full time as a consulting partner for Atzari Consulting, José served as
Director of Manufacturing Engineering at Boston Scientific and as
Quality Systems Manager at Stryker Orthopedics, where he introduced
process performance, problem solving, and quality system methodologies.
During that time he prepared a white paper on the application of lean
manufacturing methods to the creation and management of controlled
documents and a template for strategic deployment. José led the launch
of manufacturing at a start-up urology products company as Director of
Manufacturing for UroSurge, Inc. at the University of Iowa’s business
incubator park in Coralville, IA, creating a world-class medical device
manufacturing operation, with JIT, kanban systems, visual workplace and
lean manufacturing practices. José worked for 10 years at Cordis
Corporation, now a Johnson & Johnson company, where he led the
successful tooling, process development and qualification of Cordis’
first PTA (percutaneous transluminal angioplasty) catheter. His medical
device experience includes surgical instruments, PTA & PTCA
dilatation and guiding catheters, plastic surgery implants and tissue
expanders, urology implants and devices for the treatment of
incontinence, delivery systems for brachytherapy, orthopaedic implants
and instruments, and vascular surgery grafts and textiles. During his
time at Cordis, José managed the Maintenance and Facilities Department,
taking that operation to a level rated as “tops” by the UK Department of
Health and Social Services (DHSS) during one of their intensive audits.
Jose managed Manufacturing Engineering as part of the Guiding Catheter
Core Team of managers, a team that took the Cordis Guiding Catheter
business to lead the market, bringing it up from fourth place. By
introducing world-class techniques, the Guiding Catheter design and
manufacturing was completely re-engineered for robust design and
tooling, under Jose’s leadership. He was also instrumental and played a
leadership role in the complete re-engineering of the Tooling Control
System, including design drafting, the tool shop and technical support.
Wherever he has worked, he has a track record of introducing world-class
methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of
Constraints, Lean Manufacturing, Five S (Visual Workplace), process
validation to Global Harmonization Task Force standards, and similar
approaches.
If you work in the GMP-regulated industry, you not
only need to address human error deviations because they are an
inconvenience, but you must also do it because the regulation requires
it. The CFR - Code of Federal Regulations Title 21 Subpart
B_Organization and Personnel Sec. 211.22 talks about the
“Responsibilities of the quality control unit.” and it states that “(a)
There shall be a quality control unit that shall have the responsibility
and authority to approve or reject all components, drug product
containers, closures, in-process materials, packaging material,
labeling, and drug products, and the authority to review production
records to assure that no errors have occurred or, if errors have
occurred, that they have been fully investigated.” Human Error is NOT a
root cause. Human errors start at the design stage. Many variables that
affect human behavior can be controlled from procedures, training,
workplace environment, and more importantly, MANAGEMENT SYSTEMS,
reducing the likelihood of these occurrences. To work with these
challenges, it is essential to understand human behavior and the
psychology of error and implement a process exclusively dedicated to
investigating and “fixing” these problems. This course offers practical
approaches and models to address human performance issues in GMP-related
environments by using a particular methodology to correct, prevent, and
avoid the recurrence of these matters.
Learning Objectives
- Understand the psychology of error
- Organizational factors and programmatic issues
- Regulatory requirements in GMP environments for managing human performance issues
- Management Systems Root Cause Analysis
- Root Cause Determination Tool
- Establish the Human Error Rate at your site
- Implementing the program
- Metrics and KPI’s
Areas Covered
- What is Human Error?
- How is Human Error controlled?
- Types of error
- Description of Management Systems
- Company Policies
- Risk Management
- Deviation/Non- conformance management
- Product and material control
- Change Management
- Procurement/Supplier Program
- Documentation and Configuration Controls
- Validation
- Project Management & Validation
- Facilities
- Root Cause Determination
- Human error rates and measurement
- Trending and tracking
- Prediction
- Effectiveness
Who Should Attend
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
Why Should You Attend
We
need to be able to explain human behavior. Did the human fail because
of process weaknesses that set them up for failure? Do procedures
provide all information and clearly indicate critical steps and warnings
or cautions associated with steps? Do systems work for manufacturing,
or is it the other way around? These are all tough questions to ask, but
most importantly, answer. This training would provide tools to
implement and use after this event. These include practical tools. We
will discuss human error categories, near root causes, and root causes
for these events. We will discuss the latest trends in human error
issues in the industry.
-
$199.00
-
