Introduction and Foreword | IVT

Ten Years of ICH Q9, Quality Risk Management

It is with great pride that I present to you this special Quality Risk Management (QRM) edition of the Journal of Validation Technology.  As the guest editor, it has been my privilege to work with some of the greatest regulatory and industry thought leaders within the field of QRM.  This special issue consists of eleven papers, each exploring a different topic and perspective within the QRM space.  These papers reflect on how far industry has come since the inception of ICH Q9, as well as provide tangible solutions to improve the effectiveness of QRM so that it continues to deliver value to the patient.

The content of this special edition provides a wealth of information on the ICH Q9 guidance by experienced practitioners in the field.  It provides personal reflections on this decade of QRM experiences; identifies successes and deficiencies; and highlights areas for improvements with proposed solutions.  ICH Q9 has provided the potential for great value, and we have learned that we can do better to optimize that value.  Ten years of QRM implementation has yielded some important lessons: More informed decisions can be made through the lens of risk; prioritization of goals and efforts is critical, and a deeper understanding of our products and processes is possible.  Our experiences have also taught us that the effective application of QRM principles and practices is not as easy as it might appear.  But above all, the last decade has taught us that QRM enables us to deliver on our promises to our patients.  This volume seeks to present useful ideas for further discussion.  It is intended to truly represent the “state of the QRM art” after ten years of experience. 

The edition begins with an inclusive and thought-provoking piece by Dr. Kevin O’Donnell from HPRA.  In “QRM in the GMP Environment: Ten Years On... Are Medicines Any Safer Now? - A Regulator’s Perspective,” Dr. O’Donnell shares his vast experience as a GMP inspector as well as his expertise in the field of QRM.  He asks a pertinent question:  Whether the value of QRM as suggested by ICH Q9 has been realized.  His perspective is both humbling and encouraging to industry as we continue on our journey towards full risk management implementation.

Dr. Nuala Calnan and Dr. Anne Greene from the Pharmaceutical Regulatory Science Team at the Dublin Institute of Technology provide a comprehensive review of milestone industry and regulatory publications on QRM in “Has the Effort been Commensurate with the Level of Risk?  A Review of Significant Publications since the issue of ICH Q9.”  The sheer number and scope of documents they discuss are testament to the evolution in thinking that occurred since the inception of ICH Q9. 

The issue then continues with seasoned operational and quality risk practitioners Lori Richter and Ghada Haddad’s paper focusing on QRM governance and the role of senior leadership as an enabling presence.  In “Role of Senior Leadership in QRM,” they explore responsibility and accountability of key players within a holistic QRM program, including the cultural elements that are vital to successful QRM implementation.

The risk assessment portion of the QRM lifecycle is discussed through several different perspectives.  As an ex-FDA inspector with a wealth of industry experience, David L. Chesney offers us a survey of five ways QRM can go wrong, and what might be done to avoid these errors in “Five Points to Consider When Performing Quality Risk Analysis.”  Kelly Waldron contributed “Risk Analysis and Ordinal Risk Rating Scales: A Closer Look” to demonstrate some of challenges associated with typical risk rating scales and to provide additional context and suggestions to improve risk analysis.  Amanda Bishop McFarland and Kelly Waldron co-authored “Considerations regarding the use of detectability in risk assessments,” which explores how detectability may either improve or detract from the objective of the risk assessment and describes the proper use of detectability in achieving appropriate risk outcomes. 

The issue of subjectivity and bias within risk judgments is addressed by QRM expert and industry thought leader Emma Ramnarine in “Understanding Problems of Subjectivity and Uncertainty in Quality Risk Management.”  This paper provides a comprehensive overview of human heuristics and the ways in which these can lead to erroneous risk decisions as well as insight on how to minimize their negative impact.  Dr. H. Gregg Claycamp from FDA offers his perspective on the human element as well in “Expert Judgements in Quality Risk Management: Where Quality Risk Management ‘Can Go Wrong.”  This paper discusses QRM as a decision making activity and examines how expert opinion is similarly vulnerable to the effects of subjectivity and uncertainty. 

Dr. James Vesper, renowned QRM and training expert, discusses the risk communication portion of the QRM lifecycle in his piece, “Q9 + Ten Years: Examining Risk Communication.”  Dr. Vesper uses a current example of risk communication to demonstrate potential pitfalls along with easily-implementable tips on how to improve this critical activity. 

Rick Friedman of FDA authored “How Mature Quality Systems use QRM to Assure Lifecycle Process and Facility Improvement.”  In this paper, Friedman explains how the maturity and effectiveness of the quality system are linked to Quality Risk Management and knowledge management, and describes these concepts in the context of lifecycle management.  This article grounds us once again on the importance of maintaining a state of control over the medicines we make, to serve the ultimate customer—the patient. 

The issue concludes with a case study, provided by biologics manufacturing expert Dr. Aidan Harrington, illustrating how QRM can be used to improve system design and assure process control.  “Quality Risk Management and Qualification – A Maturing Partnership with Real Patient Benefits” explores the relationship between QRM and the commissioning and qualification portions of the system lifecycle, demonstrating how appropriately applied QRM can fully optimize systems during a capital project.

The contributions of all authors are greatly appreciated.  It is through their perspective and wisdom that QRM will continue evolving and improving as we pursue reliable delivery of quality medication to the patient.

Welcome to this QRM discussion.  I hope you will benefit from it, consider its suggestions and proposals, and find it useful in your work.  Speaking for the authors, it has been our pleasure to prepare it for you!   

Kelly Waldron, Guest Editor 

Ms. Waldron is currently pursuing a PhD in Quality Risk Management from the School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Dublin, Ireland. 



It is an honour to write the foreword to this Quality Risk Management 10th anniversary edition published in the Journal of Validation Technology.

I remember seeing a draft of ICH Q9 sometime in 2004, and it was evident then that the guideline was going to have a substantial impact once finalised.  Little did I suspect, however, just how significant that impact would be!  The paradigm shift has indeed occurred, and is not finished yet, but the transformational changes brought about by ICH Q9, and supported by Q8, Q10 (and to a lesser extent Q11), have fundamentally changed how we work within GMP and how the industry is regulated.  In my early years as a GMP inspector, I only rarely encountered formal risk assessment activities during inspections.  Now, the complete reverse is the case – risk assessments are being performed for almost everything!   

In the past ten years, we have seen a great many QRM-related initiatives by industry, academia, and regulators to take the concepts and guidance presented by Q9 and incorporate them into the GMP environment that we have today.  The range of topics covered in the papers and interviews within this special edition are a small testament to that, but they truly represent only the “tip of the iceberg.”  

While there is more to do, and while a number of challenges remain to be addressed, it is opportune to take a look at what has been achieved over the last ten years.  Further, we must think about what needs our focus on in the coming years.  This is what we have tried to do in this edition.  I hope you find its contents useful, but also interesting and thought-provoking. 

As we reflect, let us continue to remember the needs of patients.  Assuring the safety and effectiveness of the medicines we produce and regulate, as well as the continued availability of those medicines, requires our ongoing attention as we work to meet those needs.  When one considers the multitude of problems that are presented by medicines shortages, it is important to remember that Q9 positioned product availability as a key concern.  Q9 defined risk as the combination of the probability of occurrence of harm and the severity of that harm, and it stated that harm includes the damage that can occur from loss of product quality or availability.  Concerns over product availability are certainly more prevalent today than they were ten years ago.  There is indeed more to do! 

On a personal note, as I look back over what I have learned in the last ten years about QRM, I realise that my thoughts are very different today than what they were when I first encountered Q9.  Back then, I was more focussed at learning about risk assessment and what that involved; now, my prevailing concerns are about decision-making and decision science in general, as well as subjectivity, risk perception and risk communication, and on how to encourage the movement from risk assessment to Quality Risk Management.     

I end this note with a special word of thanks to the men and women who served on the ICH Q9 Expert Working Group.  Their work in developing a guideline that would help modernise the GMP environment from a risk viewpoint was truly visionary, impactful, and very much appreciated.   

Kevin O'Donnell  

Dr. O’Donnell is Market Compliance Manager at the Health Products Regulatory Agency (formerly Irish Medicines Board), Dublin, Ireland. 

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