Following O’Donnell’s research where the focus was on Risk Tool development, in 2014 Kelly Waldron joined the PRST as a PhD student to examine the Effectiveness and Maturity of Quality Risk Management in the industry. At the time, Waldron was the manager of Global Quality Risk Management based at Genzyme’s biopharmaceutical campus in Cambridge, Massachusetts, and was a renowned industry expert in the topic of QRM and regular speaker at international conferences. Waldron’s research examined barriers to the effective use of QRM within the pharmaceutical industry and developed a maturity framework for use by the industry to enhance the protection to the patient through more effective risk management.

Waldron, in her thesis titled “Managing risk to the patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries,” discussed how ICH Q9 offered standard principles to be applied but did not provide specific guidance on the application of these principles; that the pharmaceutical and biotechnology industries still struggle with the “how to” and, most importantly, the roles and responsibilities associated with QRM.

However, although Waldron’s research did not explore in detail how individuals can contribute to QRM effectiveness, it identified the need for role-based competency in QRM and acknowledged that the traditional training model currently being employed in the pharmaceutical sector is inadequate in building such competency, to enable a mature state in the management of risk to the patient.

Waldron added that not all QRM practitioners require the same level of training. Competencies should be based on the level of involvement in QRM. She stated that all employees should be aware of the QRM principles and practices. However, specific roles should have customized training based on their level of interaction with QRM. While certain roles may require minimal technical knowledge of QRM, those who interact more frequently and deeply with QRM will require a commensurate level of training to ensure they can fulfill their responsibilities within the program.

Although ICH Q9 outlined multiple benefits of an effective QRM program, it was silent on the need to develop strategic and tactical skills for those involved in QRM.

This gap in competency building development for QRM practitioners and decision makers became more evident with the introduction of ICH Q10, “Pharmaceutical Quality System,” which characterized QRM as a necessary enabler of an effective quality management system. Looking at the currently available data, one could argue that the adoption of ICH Q9 and 10 have not really created the benefits it promised; the reasons for this have yet to be conclusively established but can be attributed to lack of role based competency models.

Without the critical QRM knowledge required to fulfil their role, those involved in applying the principles of QRM will not understand its benefit and will not be able to sustain it once implemented.

While training is critical to QRM, it only teaches basic concepts in order to execute a task (Greene & Calnan, 2015). What is needed is the development of a framework to define and advance individual QRM maturity. Using competency models from other sectors, assessment and certification can be used to address the biopharmaceutical sector’s needs and skill gaps in QRM.

ICH Q9 highlights the need for training of both biopharmaceutical sector and regulatory personnel in quality risk management processes, in order to provide them with a sufficient understanding of decision-making processes and to build confidence in quality risk management outcomes.

QRM role-based competency model for the biopharmaceutical sector. Using a modified Delphi research methodology, seven standard QRM roles were identified and were the basis for developing the QRM role-based competency model, which included technical and behavioural competencies associated with each of the seven QRM standard roles.

According to ICH Q10, QRM should be integrated into existing operations; this in effect means that QRM should be understood by all those involved in manufacturing operations and activities. Furthermore, ICH Q9 clearly indicates that both industry and regulators need to understand QRM, the tools available, and their formal and informal application, and that product and process understanding is required when applying QRM, and that statistical knowledge helps with understanding risk.

ICH Q9 touches on the role of personnel and how those involved in assessing deviations, investigations, and complaints should have QRM knowledge (e.g., change controllers and owners should understand QRM principles to evaluate impact of changes to product quality). In addition, regulators may use QRM principles in inspection activities to assist them with resource allocation, inspection planning and frequency, evaluating the significance of, quality defects, potential recalls and inspectional findings.

Byrne, a TU-Dublin graduate student, in her dissertation titled, “An Investigation into Quality Risk Management Knowledge Held By Junior Quality And Manufacturing Roles In The Pharmaceutical Industry” (May 2019) found that the pharmaceutical industry had not yet fully embraced QRM and has not yet fully understood the potential benefit of the analysis of risk to the patient. She stated however, that the pharmaceutical industry was seeking to increase the maturity of its QRM programmes and that an evaluation of current training procedures for QRM could prove beneficial in maturing a QRM programme. Byrne concluded from her research that incorporating QRM elements into GMP training should extend to all roles within an organisation to help progress the maturity of a programme and embed a quality risk management culture.