Course Description:

Is your production system capable of efficient, effective, and compliant device manufacturing?

It does if you have the right controls in place - including documented instructions, environmental control, adequate equipment properly installed and maintained, production software that you trust, properly controlled test equipment, and validated processes - and your system implements both FDA QSR and ISO 13485:2003.

In this two-day workshop, you will learn the essentials of production and process control. Beyond the essentials, the workshop provides practical methods to help you create a robust system that produces your devices and can withstand a rigorous FDA Inspection. Breakout sessions provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters and the Quality System Inspection Technique (QSIT), provide an opportunity to learn from the experience of other companies. Discussions among participants will exchange ideas and help you uncover potential solutions.

Learning Objectives:

Establishing Production Controls

Production controls start with design output and become device production specifications through the design transfer process. While the design stage ends, production controls continue for the life of the product. You will learn how to define and establish the controls needed for production including design transfer, quality plans, documented procedures, and instructions. You'll also learn techniques to identify, monitor, and control process parameters during production.

Production and Process Changes

FDA Investigators, using the Quality System Inspection Technique (QSIT), consider production and process changes as design changes and, as a result, expect appropriate documentation. You will learn how to create procedures to manage production and process changes, verify them, and determine when to apply process validation. You will also learn the aspects of document and record control that apply to changes.

Manufacturing Equipment

Properly installed and maintained production equipment is essential for a robust manufacturing process. You will learn how to perform installation qualification (IQ) to ensure you meet the requirements, including often overlooked OSHA standards. You will also learn how to create maintenance schedules, document maintenance actions, and adjust the schedules based on experience. In addition, you will explore concepts of Total Productive Maintenance (TPM) including equipment effectiveness measurements.

Production Software

When computers are part of production, the computer software requires validation before use and before any changes. You will learn how to define the software's intended use, write validation protocols, and document the results. The workshop focuses on Excel applications to illustrate the concepts.

Controlling Inspection, Measuring, and Test Equipment (IM&TE)

All IM&TE must be suitable for its intended use and capable of producing valid results. In addition, the equipment's calibration must be documented, traceable to national or international standards, and meet requirements for accuracy and precision. You will learn what accuracy and precision mean, how they relate to traceability, and what to do when the equipment doesn't meet its accuracy and precision limits. You will also learn how to document calibration activities and adjust calibration intervals based on experience. The workshop also discusses evaluation, selection, and control of external calibration laboratories through purchasing controls.

Process Validation

Production processes require validation when the manufacturer cannot fully verify the process output. You will learn how to identify these processes and validate them using Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). You will also learn about monitoring and control of process parameters to ensure the process meets its requirements. The workshop explores both the regulatory requirements and the statistical issues in process validation to provide comprehensive understanding.

Important Linkages

Because production processes are at the center of manufacturing, they link to other significant processes such as acceptance activities, nonconforming material, corrective action, and risk management. You will learn about these linkages and their affect on production process improvement.

Who Will Benefit:

  • Production Managers and Supervisors
  • Quality Managers and Supervisors
  • Quality Engineers
  • Manufacturing Engineering Managers and Supervisors
  • Manufacturing Engineers
  • Quality Management System Auditors
  • Risk Management Specialists
  • Regulatory Affairs and Compliance Staff

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Establishing Production Controls
    • The development of the QMS (QSR & ISO 13485)
    • The current versions of the QMS (US, EU, & Canada)
    • Design output and design transfer
    • Developing quality plans
    • Writing procedures and instructions
    • Monitoring and controlling process parameters
    • Buildings and environmental control
    • Personnel
    • Contamination control
  2. Manufacturing Equipment
    • Using Installation Qualification (IQ)
    • Equipment and OSHA standards
    • Developing maintenance schedules
    • Utilizing Total Productive Maintenance (TPM)
    • Measuring equipment effectiveness
  3. Production Software
    • Identifying software used in production
    • Understanding the FDA guidance document
    • Extent of validation (risk based approach)
    • Excel spreadsheets as a common example
    • Developing a validation protocol and report
  4. Inspection, Measuring, and Test Equipment (IM&TE)
    • Accuracy and precision – what they mean
    • Traceability to national and international standards
    • When there are no standards
    • Documenting calibration status
    • Adjusting calibration intervals
    • The external calibration lab – purchasing an outsourced process
  5. Production and Process Changes
    • Identifying changes
    • QSIT and design changes
    • Determining responsibility for changes
    • Change verification
    • Process validation and change control

  1. Process Validation
    • Determining the need for process validation
    • Defining a “high degree of assurance” – process capability
    • The common phases of process validation (IQ, OQ, & PQ)
    • Monitoring, control, and documentation of process parameters
    • The role of qualified operators
    • Documenting changes and investigating deviations
  2. Labeling and Unique Device Identification
    • Device Identifiers and Production Identifiers
    • UDI on the device label
    • UDI on the packaging configuration
    • UDI on the device
    • Labeling inspection
    • Labels and UDI in the Device History Record (DHR)
  3. Acceptance Activities
    • Acceptance activities in the production flow
    • Acceptance as process control
    • Acceptance sampling – attributes & variables
    • Maintaining acceptance records
  4. Nonconforming Product & Corrective Action
    • Definitions – Correction & Corrective Action
    • Control and disposition of nonconforming product
    • Documenting nonconforming product in the Device History Record (DHR)
    • Corrective action as a process improvement technique
  5. Risk Management (ISO 14971:2007)
    • Defining and estimating risk
    • Risk reduction through production process control
    • Using Hazard Analysis and Critical Control Points (HACCP)
    • Collecting production information for risk management

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Daniel O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma black belt; he holds an APICS certification in resource management.

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