Medical Device Regulations

Regulatory Compliance for Medical Device Quality Systems (2 days)

This popular course has been taught throughout North America to medical device and regulatory affairs practitioners looking to make sense of the medical device regulations. The course compares ISO 9001:2015, ISO 13485:2016, the MDSAP (FDA, Health Canada, etc.), and the EU MDR.

Courses Scheduled: Upon Request

ISO 13485:2016 - A Best Practices Approach to Regulatory Internal Audits (2 Days)

A comprehensive tutorial on the ISO 13485:2016 requirements and how to effectively and efficiently plan, conduct and report on internal audits. Participants in this course will gain all necessary knowledge to confidently perform audits that add value to the organization. Numerous real life examples used during instruction.

You may also consider outsourcing the complete internal audit function (planning, scheduling, performing and reporting) to Orion Canada's professional internal auditors.

Courses Scheduled:       Upon Request

Putting Your Medical Device Product on the European Market (1 day)

Participants are provided with a "how to" seminar on getting a medical device compliant to the regulations required to sell in the European Union. The course is taught by one of North America's leading medical device authorities and an author of a popular book on medical device regulations. This course may be combined with a one-day Orion Canada Inc. gap assessment that identifies nonconformities and provides a roadmap for compliance.

Courses Scheduled: Upon Request

Performance Management

Lean Implementation of Quality Systems and Integrating Management Systems (3 Days)

Today quality management systems should mirror the processes that they are built on – they need to be flexible, adaptable and above all lean so they actually add value to an organization. In addition many organizations run multiple systems; e.g. quality, health and safety, environmental. This course will enable you to reduce the “red tape” traditionally associated with management systems whilst keeping them effective. Most importantly we introduce a methodology for reducing non-value add activities within an organization while listening to the voice of the customer. Specific topics include:

• Implementation of a lean system
• Customer focus – tools and techniques
• The process approach to lean systems
• Using your system to optimize processes
• Auditing the system by adding value
• Going on-line, going paperless
• Integration of management systems

Courses Scheduled:       Upon Request

Understanding Customer Requirements – the Voice of the Customer (2 days)

All organizations have processes that impact the customer. Unfortunately there is always a finite resource (human and cash) to improve these processes to meet or exceed customer requirements. This course shows participants how to analyze customers and to find out which business processes have the biggest impact on its customers. Topics include:

• Quality Function Deployment (QFD)
• Customer identification and segregation
• Customer relationship management

Courses Scheduled:       Upon Request

Optimizing Operational Processes – Operational Process Tools (2 days)

This course discusses how to optimize processes to reduce cycle time, improve service and save cash and resources at no risk to the customer. This course is provides the most value if taken soon after Understanding Customer Requirements – The Voice of the Customer. Topics include:

• Process mapping
• Critical path analysis
• Bottleneck analysis
• Flow charting
• Cross functional flow charting
• SIPOC analysis
• Measurement, assessment and metrics for process optimization

Courses Scheduled:       Upon Request

Reducing Risk (2 days)

Reducing Risk looks at the key organizational processes (discussed in Optimizing Operational Processes – Operational Process Tools) in terms of risk assessment. The course discusses approaches to determine: What can go wrong and how likely is it to go wrong? From this we can now assign resources to assign key quality tools (see course: Integrating Quality Tools for Ongoing Excellence – Operational Quality Tools) to reduce the risk to the customer. Tools include:

• Failure Mode and Effect Analysis (FMEA, FMECA)
• 5 whys
• Matrix analysis
• Introduction to cost of quality

Courses Scheduled:       Upon Request

Design for Manufacturing (3 days)

Design for manufacture is a strategy rather than a process or quality tool, although a well executed DFM strategy will drastically reduce lead times and impact quality issues. In essence in DFM the design team-work in co-ordination with the manufacturing floor and critical component suppliers to design a product that is easy to manufacture as well as meeting customer expectations. This course will address:

• Basics of Quality Function Deployment
• Failure Mode and Effect Analysis
• Overview of Design Of Experiment
• Production Part Approval Process (from QS 9000)
• Basic New Product Introduction process
• Design life cycle
• Integration of processes into management systems

Courses Scheduled:       Upon Request

Cost of Quality (2 days)

COQ aims to quantify financially the cost of poor quality as a result of defective parts or processes. This enable an organization to focus on the critical areas of high cost and vastly increase customer satisfaction. Topics include:

• Quality costing models
• 7 wastes analysis
• Activity based costing
• Dynamic cost models
• Cost reporting
• COQ in a Quality Management System
• Reducing quality costs

Courses Scheduled:       Upon Request

Facilities Layout (2 days)

Many organizations today are now decoupling their IP generation from their product or service manufacture, delivery and maintenance. The critical factor is where to place your facilities (be it a factory or a call center) for maximum strategic benefit. Topics include:

• Product layouts
• Process layouts
• Fixed position layouts
• Combination layouts
• Cellular manufacturing
• Warehouse and storage layouts
• Line balancing
• Designing layouts

Courses Scheduled:       Upon Request

Design of Work Systems (2 days)

The importance of any work system is underlined by the organizations dependence on human efforts. As one of the oldest aspects of operational development it is often the most overlooked. Today, sparked by studies indicating a significant level of dissatisfaction in work environments, there is a focus back on the design of these systems. Now they are seen as the backbone of business excellence and flexibility needed in public and private sectors. Topics include:

• Process mapping
• Critical Path Analysis
• Behavioral approaches to job design
• Methods analysis
• Time and motion study
• Work measurement
• Compensation
• Learning curves

Courses Scheduled:       Upon Request

Inventory Management and Inventory Cost Modeling (2 days)

Covers the principles of the nature and importance of inventories. Investigate the differences between dependant and independent inventory demand. Understanding the importance of demand forecasts. Inventory classification. Also considered is detailed cost modeling. Topics include:

• Requirements for effective inventory management
• Basic Economic Order Quantity (EOQ) models for non-perishable items
• Re-ordering points and frequency
• Single period models for perishable items

 Courses Scheduled:       Upon Request

Just-in-time Systems (3 days)

The term Just-in-time (JIT) refers to a production system in which the movement of material, inventory and work-in-progress during production, and the deliveries from the suppliers are carefully timed. The timing is such that at each step of the process the next batch arrives for processing just as the proceeding batch has been completed. The result is a small batch system with no idle items to be processed, and no downtime for workers or equipment. Kanban and/or Conwip tend to be precursors of JIT Manufacturing. For these concepts to succeed very careful process analysis needs to be performed and a very high integrity of product and process quality needs to be maintained.

• JIT building blocks and goals
• 5S (reducing the 7 wastes)
• Single Minute Exchange of Die (SMED)
• Kanban manufacturing control and stock replenishment
• Kanban refined – Conwip and hybrid control
• Production layout and capacity balancing
• Process mapping / critical path analysis
• Mistake proofing and in-line inspection
• Production Part Approval Process (PPAP)
• Yield management

Courses Scheduled:       Upon Request

Key Concepts in Supply Chain Management  (2 days)

Introducing the key concepts in effectively managing your supply chain your organisation will be able to gain the agility required to stay one step ahead in the marketplace. Topics include:

• Information flow in an integrated supply chain
• Process mapping the supply chain
• The basics of forecasting and demand planning
• How to avoid the sting of the bullwhip  - demand amplification
• Introduction to quality tools for the supply base
• The importance of open book costing
• The concept of pull rather that push supply
• Just-in-time supply
• Ship to stock programs
• Consignment stocking

Courses Scheduled:       Upon Request

Supply Chain Development for Manufacturers (2 days)

This course introduces key specifics for supply chain development for manufacturers. Whether you manufacture in house and purchase components or subcontract manufacture, this course will enable you to maintain a flexible, yet robust supply pipeline to minimise inventory, minimise risk and maximise customer satisfaction. Topics include:

• The issues of sourcing suppliers and subcontracting in Asia
• The realities of just-in-time supply
• Tools for ensuring component and part quality, the Production Part Approval Process (PPAP)
• Quality tools and techniques for product integrity and on-time-delivery
• Design for supplier manufacture
• How to utilise your suppliers for optimal new product introduction
• Effective methods for reducing incoming parts inspection
• Methods for the control of parts from component distribution
• How to set up a consignment stocking system
• How to be prepared – effective disaster recovery planning

Courses Scheduled:       Upon Request

If you are interested in a quality-related topic that is not listed, contact us to see if we can customize a course for you.

Problem Solving and Operational Tools and Techniques

Practical Problem Solving (1 Day)

This course provides a strong understanding of several excellent problem solving tools that will improve team performance and organizational efficiency. The instructor will review:

• Problem Solving Principles
• Stages of Problem Solving
• The Corrective Action Process
• The Preventive Action Process
• 8 Problem Solving Techniques
• The Inhibitors of Effective Problem Solving

Consider having Orion Canada facilitate team meetings, strategy sessions, management reviews or project post mortems.

Courses Scheduled:       Upon Request

Basic Statistics for Organizations (2 days)

Participants are taught the basic statistical techniques required for data analysis. Topics include:

• Discrete and continuous distributions
• Statistical metrics
• Uncertainty and population
• Basic t-test
• Analysis of variance
• Applications in business

Courses Scheduled:       Upon Request

Introduction to Statistical Process Control - SPC (2 days)

Statistical control charts are an important element of the process control system. They are used to chart a pre-defined quality characteristic and can be used to monitor the variation in a process. They are also used to predict certain events (normally out of control conditions) that are due to assignable variations in process output. Tools taught through this course include:

• Gauge R&R studies
• Stewhart control charts (attribute and variable)
• Non-Stewhart charts (e.g. EWMA)
• Process capability indices (Cp, CpK)
• Setting up SPC as part of a process

Courses Scheduled:       Upon Request

Introduction to Design for Experiment (2 days)

Design of Experiment (DOE) is a family of techniques that enable an engineer to home in rapidly on the most important variables in new product design or process improvement. DOE techniques choose statistically correct “combinations” of the variable settings to give us a mathematically accurate insight into the product or process. This course gives an overview of the different methodologies and examples, including:

• Design Types (full factorial and fractional factorial experiments)
• Statistical techniques
• Design Evaluation
• Robust design (Taguchi philosophy)
• Optimization methods

Like all Orion Canada courses, this course may be further customized to meet a client's requirements. For example, more detailed instruction on DOE is available on request.

Courses Scheduled:       Upon Request