On 29 July 2009, Australia’s Therapeutic Goods Administration (TGA) adopted the PIC/S Guide to Good Manufacturing Practice PE009-8.
One of the single biggest changes from the previous Australian Code of Good Manufacturing Practice was, and remains, the codification of Quality Risk Management (QRM).
The industry was unprepared for the impact of QRM and, although the concepts of QRM have been widely communicated and debated, it is apparent that some continue to struggle with the implementation of effective QRM systems.
So, with all of this in mind, let’s consider some of the key aspects for successful QRM implementation.
A Systematic Approach
“The manufacturer shall establish, document and maintain, throughout the life-cycle, an ongoing process for identifying hazards…”
Consider what QRM methodology is most suitable for your processes and products, and how it will be integrated into your QMS.
QRM must give you real tangible benefits to your organisation so be sure that QRM criteria are established throughout your organisation, so that everyone is able to make a considered decision based on each criterion.
Standard Operating Procedures can be readily developed, however making decisions early in the process can make QRM implementation much simpler.
Consider the risk register used to document all risk efforts performed. Will you have one risk register per department, per business unit, per process or one register for the entire organisation?
Keep in mind that risk reviews are mandatory so your risk registers will be referred to frequently, for example, following change control, to verify the adequacy of the original risk assessment and to ensure the risk assessment is repeated before change implementation.
“The quality risk management system should ensure that: The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient;…”
Scientific knowledge is the cornerstone of QRM – it is designed to eliminate assumptions by gathering verifiable evidence and appropriate research.
At times you will identify uncertainties or gaps in knowledge – use all available means, including subject matter experts, to address these gaps so that you can comprehensively identify all the risks. Remember that QRM is designed to improve communication and knowledge within your organisation.
Finally, scientific knowledge is not about using QRM to justify non-compliance. Science-based QRM must lead to improved patient safety and product quality.
Experience with the Process
Experience with the process refers to experience with:
- the process under review, and
This requirement ensures that those involved in the QRM effort have expertise and can contribute effectively.
Consider the level of knowledge people in your organisation have with the process, is the process well understood or “non-standard”, novel and featuring several complexities and interfaces? This information should influence your QRM decisions.
Establishing and Maintaining the System
QRM should by now have permeated or been formally introduced to all components of the Quality Management System.
Quality systems that should have already felt this impact include: deviations and investigations, CAPAs, complaints, change management, supplier management, validation and qualification, auditing, product quality reviews and control strategies, among many others.
QRM requires that it must be reviewed as part of the quality management system.
QRM reviews are not always well considered. For example, do you ever think about reviewing past risk decisions?
Determine what will initiate a review of your QRM efforts. Consider scheduling risk review by:
- Linking it to change management and customer complaints.
- Scheduling regular reviews of QRM efforts.
- Considering it when there is new knowledge or experience
Understand the lifecycle of the process under review – by definition, QRM applied during Quality by Design will be very different proposition to QRM applied to legacy processes.
It is clear that, going forward, GMP updates will include QRM considerations. QRM requires careful assessment and well considered decisions, but the benefits can far outweigh the time and resource demands.
ISO 14971:2007 Medical devices – Application of risk management to medical devices
EN ISO 14791:2012 Medical devices – Application of risk management to medical devices
ISO 13485:2003 Medical Device – Quality management systems – Requirements for regulatory purposes
ICH Q8 Pharmaceutical Development
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System
PIC/S Guide to Good Manufacturing Practice PE009-8 January 2009