Risk Management and Impact Assessments in Change Control

Change control or change management is an integral part of todays regulated pharmaceutical and medical device industries (as well as others). The need to control and assess changes being made to previously approved documents ensures that any and all changes are implemented in a careful and thoughtful way. 

An all too common observation during a regulatory audit or during a product nonconformance investigation is that changes were made to the product through the product documentation that were actually harmful to the product performance or that proper studies were not undertaken to ensure the product continued to meet design goals. Another consequence of an inadequate change control strategy is when making changes to one product adversely impacts another product or multiple products. 

When assessing changes, it is important to take risk management into consideration before, during and after the change. Determining the risk level of the change can guide how or even if the change is implemented.

LEARNING OBJECTIVES:

• Understand the change control process.
• Understand the critically important impact assessment process and develop tools for effective impact assessments.
• Learn how to integrate risk management into the change control process.

AREAS COVERED IN THE SESSION:

Impact assessment as a part of change control

• The ability to assess the impact of a change is integral to the process of change control
• Must be an integral part of your change control procedure
• Not an option

Why do an impact assessment as part of change control?

• Regulatory guidance talks to ensuring all changes are reviewed, verified and/or validated as appropriate
• Determination of “appropriate” is a little vague. 
• Regulatory guidance does not provide much guidance on how to do an impact assessment
• The process and procedure must be part of internal SOPs

Quick review of the elements of a change description

• The change
• The reason
• The justification
• The justification comes from the impact assessment
• You can’t justify the change without assessing the impact of the change first
• Low impact changes
• Not all changes require a comprehensive impact assessment
• There should be a predefined list of changes or change types that do not require a full impact assessment to justify
• This list of changes or change types should be part of an SOP and fairly short and well defined

Impact assessment team

• If it is determined that a full impact assessment is needed a team to do the assessment should be put together
• Can be permanent group or put together as needed
• Need someone to drive the change
• Acts as the project manager for the change
• Other functional areas depending on the nature of the change

Creating a change control roadmap

• The use of forms and decision trees is essential to success
• Team needs to have guidance and a place to record impact decisions
• Examples of decision tree and change impact assessment form
• Understanding of risk management impact
• Simple tool for risk management during change control
• Understanding regulatory impact

Conclusions and questions.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Validation Professionals
• GMP Trainers
• Auditors
• Consultants

Course Director: ALAN M. GOLDEN

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years. Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance. Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.