Application of Risk Management to Medical Devices

2-Day Schedule: 7:30 AM – 4:30 PM MST   Audience: Beginner to Advanced

ISO 14971 Training Overview

This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Medical Device Manufacturers, these same techniques learned in this ISO 14971 training can be used regardless of the products or services offered by your organization.

 

Who Should Attend? Anyone who needs to develop and implement a comprehensive Risk Management Program meets requirements for ISO 14971:2019 Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk Quality Managers Engineering Managers Internal and external auditors Design Teams Management Representatives Project Teams Anyone who needs to understand the difference between Risk Identification, Risk Assessment and Risk Management and how to put these important tools to work for your organization.

 

Agenda

Day 1 

• Risk terminology and theory from ISO 14971 and ISO 13485
• History of risk management and relationship with Corrective and Preventive Actions
• Requirements of ISO 14971

• Design of framework for managing risk
• 4.3.2 Establishing risk management policy
• Integration into organizational processes
• Establishing internal communication and reporting mechanisms
• Establishing external communication and reporting mechanisms
• Implementing risk management
• Implementing the framework for managing risk & risk management process
• Continual improvement of the framework
• Communication and consultation
• Establishing the internal and external context
• Establishing the context of the risk management process
• Defining risk criteria
• Risk assessment

• Risk identification
• Risk analysis
• Risk evaluation
• Risk treatment

• Selection of risk treatment options
• Preparing and implementing risk treatment plans
• Monitoring and review
• Recording the risk management process
• Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis

Day 2

• Guidelines from ISO 14971
• Techniques – Risk Management
• Selection of risk assessment techniques

• Selection of techniques
• Availability of Resources
• The Nature and Degree of Uncertainty
• Complexity of risk
• Application of risk assessment during life cycle phases

• Types of risk assessment techniques

• Flow charts and process mapping
• Brainstorming
• Risk Checklists
• Delphi Method
• Process FMEA
• Design FMEA
• Fault Tree Analysis (Event Tree Analysis)
• HAZOP & HACCP
• Cause & Effect with 5-Whys & 7-M
• Preliminary hazard analysis
• Risk Ranking and Filtering

• Case Studies with application
• Organization’s Risk Procedures and Tools

• Case Studies from Organization’s Risk Analysis, Treatment and Monitoring

• Risk Applications for Medical Devices

• Internal Audit
• Training
• CAPA System
• Supplier Selection & Control
• Outsourcing – Special Processes
• Facilities and Equipment
• Design & Development
• Production and Process Controls
• Process Validation and Re-Validation
• Servicing

• Design FMEA Case Study
• Various Risk Case Studies
• Organization’s Case Studies
• Statistical Methods
• Test

Risk Management for AS13004

Days: 2 

 7:30 AM- 4:30 PM MST

AS13004 Overview

This class teaches participants the Aerospace Risk Requirements (per AS9100, 9110, and 9120) as well as the specific requirements for Operation Risk as defined in AS13004 PFMEA and Control Plans.  The course follows a well-organized, systematic approach to Identify, Assess, and Mitigate Risks that impact Aerospace organizations and the risks to their customers and stakeholders. While Risk Management is a basic requirement of ISO 9001, the Aerospace standards incorporate all of these requirements and add further requirements to make aerospace products and services safe and effective throughout the Supply Chain. Further, with reduced risks inherent in the Design and Manufacture of aerospace articles, the costs associated with their manufacture should be reduced.

Who Should Attend Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk. Organizations that must meet the requirements–AS9100 Operational Risk Management, and AS13004 PFMEA and Control Plans. Quality Managers Management Representatives Engineering Managers Internal and external auditors Design Teams Project Teams

What you will learn

• How to address Risk-Based Thinking requirements of ISO 9001:2015 and AS9100 (per ISO 31000).
• How to address the Operational Risk Management requirements of AS9100 (per AS13004).
• Tools used for Risk Assessment such as DFMEA, Process Flow Diagrams, PFMEAs and Control Plans.
• How risk management can be applied to any organization, regardless of its products or customers.
• A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed.
• How to quantify risk as the first step in establishing priorities for your organization.
• Methods for controlling risks within your Supply Chain

AGENDA

Day 1

• Risk terminology
• Four-step Risk Management process outlined in ISO 31000
• Risk-based Thinking requirements of ISO 9001:2015 and AS9100D
• Strategic vs. process risk management
• Tools, methods, and a streamlined approach for addressing risk-based thinking requirements.
• Hands-on exercises

Day 2

• Aerospace risk terminology
• Overview of APQP and PPAP risk tools: Process Flow Diagrams, PFMEA’s and Control Plans
• How to develop a Process Flow Diagram (identifying process risks)
• Guidelines for performing a Process Failure Modes and Effects (FMEA) analysis
• Creating an effective Control Plan used to manufacture and control and resolve ongoing process risks
• Detailed hands-on case study developing an FMEA analysis, with tools for completing each stage
• Requirements for Operational Risk Management
• Overview of AS13004 – Process Failure Modes and Effects Analysis and Control Plans
• Guidance on using AS13004 methodology to meet Operational Risk Management requirements

Days: 2 

 7:30 AM- 4:30 PM MST

Learn CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals

Come learn the FDA 21 CFR and ISO 13485 requirements for a regulatory-compliant CAPA system and records. You will leave this training knowing how to perform effective root cause investigations that address, resolve, and prevent the issue(s) from recurring. This same CAPA methodology can be used to address Regulatory audit findings throughout the world.

This course teaches:

✔ The regulatory requirements for pharmaceutical and medical device CAPA:

• 21 CFR Part 4 – Good Manufacturing Practices for Combination Products
• 21 CFR Part 820 – Quality System Regulations for Medical Devices; Good Manufacturing Practices for Devices
• 21 CFR Part 801 – Labeling of Medical Devices
• 21 CFR Part 201 – Labeling of Drugs
• 21 CFR Part 210 and 211 – Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding Drugs
• ISO 13485:2016 – Quality System Requirements for Medical Devices (and comparison to MDSAP and EU MDR/IVDR requirements)
• EU MDR CAPA Requirements related to: Article 83 PMS, Article 10 Manufacturing, Article 89 Serious Incidents

✔ How to perform effective fast-paced root cause analysis and complaint investigations– no more “best-guesses”

✔ How to document complaint investigations and maintain records to demonstrate compliance

✔ Root cause investigation methods, such as: The 5 Whys: Including 5-Whys Tree and 3×5 Whys (or 3-legged 5-Whys) Fault Tree Analysis Cause and Effect Flow Charting Pareto Charting Fish-bone/6 M approach (Man, Method, Machine, Material, Milieu (Measurement & Mother Earth)

✔ Other helpful pharma & medical device CAPA Tools including:

• 5-W 2-H and 5-W 2-H Proof
• FMEA
• Containment approaches
• Incident Risk Analysis
• Paynter Charts
• Layered Process Auditing
• Corrective Action Plans
• COPQ approach to CAPA profit enhancement

Learning Objectives:

1. Learn and practice within a compliant corrective action & preventive action (CAPA) process.
2. Learn how to perform effective root cause investigations.
3. Learn and understand when and how to apply the appropriate root cause investigation tool/method.
4. Learn and understand which records are required to demonstrate compliance to the FDA’s CFR Part 4 and CFR Part 820 regulations and ISO 13485 requirements.
5. How to establish effective corrective action plans.
6. How to plan & perform a Verification of Effectiveness (VoE) to assess if the corrective actions resolved the root of the problem.
7. Learn how to keep the CAPA process SIMPLE, effective, and adding value while reducing costs.
8. Learn how CAPA and Kaizen Events (Proactive) work together to demonstrate compliance.
9. Learn the interrelationships between: Nonconformities, Complaints, Post Market Surveillance and QMS monitoring and statistical techniques

Who Should Attend

• Do you do Corrective Actions? – THEN YOU SHOULD ATTEND!
• Quality Engineers (QE)
• Manufacturing Engineering (ME)
• Process Engineers & Technicians
• Electrical Engineers (EE) and Technicians
• Top Management – Why? They are ultimately responsible for ensuring the CAPA system is working effectively.
• Operations Directors & Management
• Engineering Directors & Management
• Marketing Directors & Management
• Manufacturing Directors & Management
• Regulatory Directors & Management
• Quality Assurance Directors & Management
• Purchasing Managers
• Supply Chain Managers who deal with SCAR and CAR processes.
• ANYONE WHO THINKS THEY KNOW MEDICAL DEVICE CAPA but really doesn’t get it, making them a prime target for a HUGE FDA finding that will ROCK their world and WASTE ALL SORTS of time and resources.

Class Agenda

Day 1

• Overview – Why CAPAs are required
  • Overview of the Regulatory requirements for CAPA in the following countries:
  • USA (FDA)
  • Australia (TGA)
  • Brazil (ANVISA)
  • Canada (CMDR)
  • Japan (PMDA)
  • European Union (including BREXIT)
• Typical Problems with Root Cause Investigations
  • Why most problem-solving models don’t get to the root cause and a solution
  • How analytical and creative thinking must be both separated and integrated
  • Difference between content and process thinking
• Responsibilities for Root Cause and Corrective/ Preventive Action
  • Top Management, Operation Management, Marketing Management, Engineering, Quality, Design, Frontline Management, Supervisors, Worker
• Step 1: Assigning a corrective action team leader: cross functional team
• Step 2: Describing the problem – COPQ
  • Activity – Risk Ranking for Quality Events – Deciding: Proportionate to the Effects
  • Activity – Medical Device CAPA Case Study #1: What constitutes an effective CAPA?
  • Activity – Detailed problem descriptions
• Step 3: Containing the problem
  • Case Study – CAPA Case Study #2: What is proper Containment of the problem?
• Step 4: Identifying the root cause or causes
  • System, process, & product causes
  • Root cause/data investigation tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
• Data Collection and Analysis
  • Check sheets, graphs, and tables for discrete data collection
  • Surveys, interviews, and field observation for opinions or less precise data
  • Activity – “5 Whys” method, 3×5 Whys, 5-Whys Tree
  • Activity – Ishikawa or Cause & Effect Diagram

Day 2

• Step 5: Verifying the root cause or causes
  • Activity: Likely Cause Worksheet: CAPA Case Study #2
  • Activity: 5-W 2-H Proof: CAPA Case Study #2
  • Pareto or 80/20 Rule, I can’t work EVERY cause, which ones?
• Step 6: Implementing corrective actions
  • Band-Aids vs Long-Term improvement: ST, IT and LT Corrective Actions
  • Corrective Action Plans: managing resources and achieving permanent improvement
• Step 6a: Risk Assessment: verify CAPA does not impact regulatory or safety requirements
  • Risk Management Process: ISO 14971 MD application of Risk Management
  • Hazards, Hazardous Situations and Harms – keeping your device Safe and Effective
  • Determining Probability of a Hazardous Situation presenting itself (P1), and of a Harm resulting (P2)
  • Activity: FMEA for CAPA Case Study #2
• Step 7: Verifying corrective action effectiveness
  • Production Process Audits: are proactive controls In-Place
  • Layered Process Auditing: Effecting permanent Change in your Organization
  • Crafting Effectiveness Check plans for each Corrective Action
  • Activity: Effectiveness Plan: CAPA Case Study #2
  • Paynter Charting: temporary Effectiveness Check
• Step 8: Closing the Corrective Action – Finally ALL DONE
  • Considering Preventive Actions:
    • Preventive vs. Corrective Actions: FDA and Final Rule FDA 820 Considerations
    • FMEAs – it’s all Preventive or Proactive
    • 3×5 Whys and “Read Across”
  • Congratulate the TEAM!
• Course Insights and Final Exam

Root Cause Analysis, Corrective Action and Preventive Action CAPA Training

Days: 2

 7:30 AM- 4:30 PM MST

Who Should Attend Employees responsible for conducting or managing corrective actions Quality managers, engineers, and auditors involved in CAPA processes Supervisors and frontline managers overseeing process improvements Production and operations personnel responsible for identifying and resolving issues Regulatory and compliance professionals ensuring adherence to quality standards Team members involved in problem-solving initiatives or process improvement projects Anyone seeking a structured approach to root cause analysis and corrective action

Root Cause Analysis & CAPA Training Objectives

1. Understand the ISO requirements for Corrective Action, Risk-Based Thinking, and/or Preventive Action.
2. Experience a variety of tools and methods for performing Root Cause Analysis (RCA).
3. Learn a variety of methods and tools for performing effective Corrective Actions.
4. Understand when a full RCA is necessary or when an Apparent Cause Analysis or Correction Only is preferred.

Agenda

Related Courses

CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training	AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training	ISO 9001 Lead Auditor Training	Human Factors Training

Days: 2

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Overview

Human Factors is a term that appears in the latest versions of several ISO standards, including:

• ISO 9001:2015 General manufacturing QMS
• AS9100D:2016  Aerospace QMS
• ISO 14971:2007 Risk management for medical devices
• ISO 45001:2018 Occupational health and safety

This Human Factors online training helps you to understand human factors in the context of each standard.  You will learn how to apply the concept of human factors to your management system and address the standard requirements.  You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.

As with all of Axeon’s courses, this is a practical, how-to that is not bogged down in academic discussions.  We use case studies, practice exercises, and learning activities to keep the training activities and build competence.

Who Should Attend our Human Factors Online Training?

Prerequisites

None.  Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it.

Course Objectives

• Understand the requirements of human factors in the context of each standard.
• Learn how to address human factors within your organization’s quality and/or safety management system.
• Provide practical tools and methods for addressing human factors.

Agenda

Day 1 

Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard

Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action

Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors

Day 2

Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety

Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance

Final Test

Days: 1

Time: 7:30 AM-4:30 PM MST

Audience: Top management

Overview 

A QMS (Quality Management System) is NOT a cost of doing business.  It’s an investment.  And top management should expect to get a financial return on that investment.  However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.

The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015.  In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.

Why Attend?

This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.

If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.

Who Should Attend?

• Top management from organizations with quality, environmental, or safety management systems, including chief executives, general managers, and other senior managers.
• Quality Managers and/or Management Representatives
•  Anyone considering implementing an ISO quality system

Course Objectives

• Understand the new top management ISO requirements and how to accomplish them.
• Understand the responsibilities that can be delegated to a management representative, and those responsibilities top management must retain.
• Learn how to maximize the ROI from your management system.
• Receive practical methods, tools, and tips for using your QMS to enhance organizational performance.
• Learn the mistakes to avoid that can negatively impact your management system.
• To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system

Agenda

Benefits of a Quality Management System

• Overview of Potential Benefits, including Return on Investment (ROI)
• Why Top Management Leadership and Commitment is Important.
• Creating an Organizational Culture that Supports Quality.

Overview of Quality Principles

• What is Quality?  What is Quality Management?
• Top Management Responsibilities (per ISO 9001) and How to Accomplish Them.

How to Maximize the ROI from your QMS

• ROI Depends on an Organization’s Level of Commitment to its QMS System.
• Using your QMS processes to ensure Customer Satisfaction and Increase Profitability.
• Using the Process Approach to Manage Quality (Turtle Diagram).
• Establishing KPIs and Determining Process Effectiveness.
• Continuously Improving your QMS.
• Reducing the Costs of Poor Quality (COPQ).
• Using Your QMS to Manage Risks and Support Your Strategic Direction.

The Five Biggest Mistakes Executives Make with Quality Management

Final Test