Risk Management Plans have been used as best business practices for many years, especially in high-risk business environments experiencing reduced resources with increased liabilities.

Every product, system and process has associated risks. In the pharmaceutical industry, robust risk management methodology is essential to identify and evaluate risks faced, and generate intervention plans to reduce risks to acceptable levels.

It’sQA can assist you with the design, development and implementation of the Risk Management Plan in all of its elements including Strategic Safety Programmes, Product Risks and required interventions when appropriate, and validated metrics.

We offer support with the following:

Development of a Risk and Issue Management Strategy

To define the approach, responsibilities and activities required to effectively manage risks and issues, the manner in which risks and issues will be handled by responsible individual(s) and how risks and issues will be raised, analysed, reviewed, communicated and escalated.

Development of a Risk and Issue Management Plan

To document the strategy for managing risks and issues, describing the corresponding approach, responsibilities, activities and tools.

Risk Identification Techniques

To provide methods for identifying the risks that could affect the safety, quality, reliability or durability of a product, process or programme and for organising the risks in order to evaluate them and plan appropriate responses. Sometimes this is referred to as a “Hazards Analysis”, often used in conjunction with “Failure Modes and Effects Analysis".

Risk Evaluation Techniques

To assess the priority and severity of identified risks that threaten the safety, quality, reliability or durability of a product, process or programme. Risk Evaluation Techniques allow project teams to assess risks relatively quickly and to organise subsequent action.

Impact Criteria Determination Techniques

To help you identify project areas or product attributes that might be affected by a risk or a problem and to establish the criteria used to evaluate the impact of problems or the potential impact of risks.

Development of Risk Response Planning Techniques

To determine how to react to specific risks or problems, such as: accepting a risk as it is; changing the product, process or programme; avoiding the risk altogether; or actively pursuing ways to reduce the risk’s threat to the product, process, or programme.


To ensure that all of the necessary Risk Management Procedures have been identified and completed and reviewed at key milestones throughout a project.

Contact It’sQA today for all your risk management needs.