Tools and advice to make the best use of Quality Risk Management

Tools and advice to make the best use of Quality Risk Management

Quality Risk Management is a forecasting model and a systematic process for assessing, controlling, communicating and reviewing risks to the quality (understood as safety and effectiveness) of a product or service throughout its life, from development to marketing.

QRM can be applied to different types of industries, such as Automotive and Food, but also to different areas of the company, from quality control to human resources.

Quality Risk Management is important for providing a structured and objective approach to the management of information and decision-making, through documented, consistent and communicative methods that support the development and production phases of the product or service.

In the Life Science sector, QRM is addressed in the ICH Q9guidelines, in Part III of the GMP Guidelines, where the development of science and risk-based approaches to quality is encouraged.

4 advantages of Quality Risk Management

1. Quality

Effective implementation of the entire Quality Risk Management process ensures high-quality medication for the patient. This is achieved through a proactive approach of identifying and controlling possible quality problems that may occur during its development and production (including raw ingredients and packaging materials).

2. Decision making

Systematic application of QRM also improves decision-making and increases confidence in the company’s ability to deal with potential risks.

3. Productivity

Furthermore, when well applied, Quality Risk Management significantly reduces the costs of pharmaceutical product development and production by reducing an organisation’s workload and focusing efforts on the most critical areas leading to higher product quality and patient safety chains.

4. Knowledge anagement

QRM can also be successfully used to enhance knowledge management by providing a comprehensive overview of processes or systems, their weaknesses and the critical controls that have been put in place to prevent problems from occurring.

Some methods and tools to support QRM

5 Whys

The method is to repeatedly ask the question “why” until you come to understand all the symptoms of a problem and get to the root. The method is usually used during problem-solving activities or in conjunction with other tools, such as the cause and effect diagram.

Ishikawa Diagram (fishbone diagram)

So-called because it looks like a fishbone with a rectangle at the end containing the effect or problem. In the manufacturing field, the causes or factors that influence a production process are often organised into four macro groups, which are: labour, machines (including the energy used and working and measuring instruments), materials (raw and auxiliary materials) and methods (procedures or operating practices). It can be used in brainstorming sessions with the team.

Fault Tree Analysis (FTA)

This helps determine the cause of failure or tests the reliability of a system by logically checking for a series of events. The FTA starts from failure to logically arrive at the causes. It can be used for:

  • establishing the route to the right cause of failure;
  • evaluating the system or subsystem of failures one at a time, although it can also combine several causes of failure by identifying causal chains;
  • investigating complaints and deviations so as to fully understand their cause and ensure that the planned improvements will solve the problem and not lead to others;
  • evaluating how different factors influence a certain problem. It is useful for both risk assessment and monitoring development programmes.
  • It relies on a total understanding of the process so as to identify causative factors.

Failure Mode and Effect Analysis (FMEA)

Methodology used to analyse failure or defect modes of a process, product or system, analyse their causes and assess their effects on the whole system/plant. Generally (but not necessarily) the analysis is carried out beforehand and is therefore based on theoretical and not experimental considerations. It allows organisations to anticipate possible defects and errors in process design during the design phase.

It can be used for:

  • designing a new product, process or service;
  • planning to carry out an existing process in a different way;
  • when you have the objective of improving the quality of a specific process;
  • when you need to understand and “improve” the errors in a process.


Tool based on the theory that risk events are caused by deviations from the design or operational goals. It uses a systematic technique to identify potential deviations. It is often used by a team that already knows the design of a process or product and its application.

It can be used for:

  • production processes;
  • equipment and services;
  • finished products and raw materials;
  • assessing the dangers within safety processes;
  • as a starting point for the HACCP methodology;


Identifies and implements process controls that consistently and effectively prevent the occurrence or spread of dangerous conditions. It emphasises problem prevention rather than its detection, which is why it is recommended for proactive and non-reactive applications.

It can be used for:

  • identifying and managing the risks associated with physical, chemical and biological hazards (including microbiological contamination);
  • supporting the identification of critical control points (critical variables/parameters) when product and process knowledge is comprehensive;
  • facilitating the monitoring of critical points in production processes.

Preliminary Hazard Analysis (PHA)

Analysis tool that applies experience or prior knowledge of the hazard or failure to identify future hazards, hazardous situations and events that could cause harm and to assess their likelihood of occurrence in relation to a certain activity, product functionality or system.

It can be used for:

  • analysing existing systems or prioritising hazards where conditions preclude the use of a more extensive technique;
  • products, processes and functionalities and to assess the types of hazard by product type or class and for the specific product;
  • the development of a project when there is little information on the detail of the design or operational procedures (i.e. it is often a predecessor of later studies);
  • in general, the hazards identified are assessed with other risk management methods

MORE INFO: The challenges of Change Control including sharing, documentation, training and digitisation

Risk Ranking and Filtering

Method used to compare and classify risks. It usually includes the evaluation of several quantitative and qualitative factors for each risk and risk weighting and scoring.

Can be used:

  • to prioritise production sites for inspections and audits by regulatory bodies or the industry;
  • in situations where the portfolio of risks and the underlying consequences to be managed are different and difficult to compare using a single instrument;
  • when management needs to address both qualitative and quantitative risks in the same organisational structure.

To learn more about other tools, we recommend the World Health Organisation’s Quality Risk Management Guidelines.


QRM management with a digital system




PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.

The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.


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An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes


Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes