How can the life science industry meet the authority requirements for risk analysis and management?

We have more than 10 years' experience with GMP services for the life science industry, including how to interpret authority requirements in relation to the implementation of Quality Risk Management (ICH Q9) and quality risk management as part of the company's risk assessment . We want to be the leading consultants and have performed many risk analysis projects since ICH published Q9 in 2006.

Gitte: Back in 2006 I gave presentations onSelecting the proper tool for Quality Risk Management”. Ung og uerfaren, var jeg af den vildfarelse at intet var mere vigtigt end værktøjet for at opnå en god risikoanalyse og risikovurdering. Mange risikoanalyser senere har jeg erfaret, at det absolut ikke er sandt. Det væsentligste er: plan it, get it done and documented. In the follow article I will share some of my experiences and most important points when working with Quality Risk Management.

Scoping is important for risk management

Our experience with risk analysis is that #1 pitfall is that scope is not defined or agreed upon prior to risk analysis: what is the beginning and end of the process and / or the system, and what interdisciplinary disciplines are involved. In the GMP risk analysis, risks related to product quality (Patient risk) must be identified.

Although it is interesting to include other disciplines (non-GMP), for example, business risks, environmental considerations, etc., in our experience it is difficult to manage and difficult to score when the challenges are combined.

The cross disciplinary team

Setting the cross disciplinary team, is the #2 pitfalls in managing quality risk. It is a mistake to believe it’s a one man job because the analysis should be done in a cross disciplinary team with discrete expertise represented. Bringing the cross disciplinary team together - no observation should come up alone. The intrinsic factor is that people should be gathered together listening and sharing experiences. The most important learning is to have the process facilitated, and making sure the right competencies are present. AlfaNordic has the expertise of facilitation the teamacting as meeting facilitator, oras Subject Matter Expert in certain technical/scientific topics.

Scientific and risk based approach is the key

I would like to emphasize the need for a science and risk based approach. The more relevant data that can be added to the analysis, the more knowledge-based results can be obtained. ICH Q9 accepts that level of effort; formality; and documentation may vary for risk analyzes, but is consistent with perceived risk scores.

Risikoanalysen kan indeholde detaljerede analyser, beskrevet i lange tekster, dog anbefaler jeg, at der benyttes grafiske illustrationer så pointerne er lettere at gennemskue. Målet er, at risikoanalyserne afspejler virkeligheden, dog kommer de reelle katastrofer oftest, når der er flere fejl der opstår i kombination.

Risk Assessments are not expected to be a one-off exercise, contrary it is required throughout the total product lifecycle.

Quality Risk Assessment in qualification, scale up and validation task

  • Quality risk analyzes of products, e.g. Design Validation for Medical Devices
  • Quality Risk Assessment of critical processes and system designs
  • Quality risk analyzes during qualification scale-up and validation
  • Risk Ranking and establishment of as low as reasonable practicable
  • Project risk management e.g. due diligence at acquisitions
  • Priority / screening tool for suppliers and contractors
  • Training in selected tools for risk assessment
  • Development of tactical and operational procedures for the design of a Quality Risk Management System
  • Optimisation of current Quality processes, evaluation of relevant in-process control, design control strategy

Good reasons to do your risk assessment thoroughly

  • It is a regulatory expectation
  • It is Common sense
  • Achieve further knowledge of your process/product
  • A structured way to collect and evaluate the performance of the process – and critical quality attributes during the products lifecycle
  • A tool to think cross-disciplinary around the process
  • Efficient planning of your resources

AlfaNordic’s quality team are trained in the principles of Quality Risk Management and we can guide and facilitate you through risk analysis sessions and we will be able to contribute with several Subject Matter Experts to join your cross-disciplinary team in case any competences are not present in-house at customer.

Read more at .

The article is written by AlfaNordic’s director of Quality Gitte Lyngø Nielsen.


Risk analysis is about identifying any risks and managing them in connection with the implementation of new processes, functions and systems. This is done through a number of tools within Quality Risk Management (such as FMEA).


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