Risk Management Master Plan

Regulatory agencies (e.g. US FDA) focus during inspections on high risk systems. Inspectors want to know your approach towards risk assessment and control.

This risk management master plan is the ideal tool

• That makes risk management and assessment for individual projects most effective.
• It is the single most important risk document to improve consistency of risk management throughout your organization.
• Optimization of risks vs. costs , efficiency in your organization through reuse of templates, confidence for inspections of computer based systems.

This model master plan written by Dr. Ludwig Huber is both concise and comprehensive. Whether you use it as it is or as a template for customization: it saves time and increases confidence for inspections. Includes example SOPs: Risk assessment for 21 CFR Part 11 and Risk based validation of computer systems .

Product Description:

Purpose and Scope of this Master Plan

• This plan provides a framework and practices for risk management of processes, equipment, computer systems and networked systems for laboratories, offices and manufacturing.
• It is also applicable to risk management during software development and development and use of Macros and Spreadsheet applications.
• It applies to new and to legacy systems.
• The Risk Management Master Plan should ensure that risk assessment and control are carried out efficiently and consistently throughout the organization as well as meeting regulatory, customer, quality and business requirements.
• The plan should ensure that the company's risk management procedures are understood and followed
• throughout the organization.
• The company Risk Management Master Plan is the basis of individual Risk Management Project Plans.

This master plan describes:

• The approach to the company's risk management.
• Who in the organization is responsible for what?
• Other documents related to risk management plans.
• Which products and processes need risk management?
• Contents of individual Risk Management Project Plan.
• How severity and probability are defined.
• Factors contributing to high and low severity
• How to make a high-level risk assessment.
• Detailed steps for risk management.

Specific examples are given for:

• Computer systems
• Network infrastructure
• Macros and Spreadsheet applications
• Legacy systems

The concepts and examples given can also be applied to other systems.
Towards the end you will find a glossary and templates for easy implementation.

Who will benefit:

Risk management involves a lot of departments, functions and people. This chapter identifies all risk management responsibilities for people like from the -

• Validation team
• QA
• Risk management team
• Operations
• Plant Maintenance/engineering
• IT
• Consultants
• Vendors, users etc.